Drug Approvals for July 2002

Definitions and Notes

Original New Drug Applications

Original New Drug Application # 021409
Approval Date: 26-JUL-02
Trade Name: SINGULAIR
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: GRANULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): MONTELUKAST SODIUM
OTC/RX Status: RX
Indication of Use: PROPHYLAXIS/CHRONIC TREATMENT OF ASTHMA

Original New Drug Application # 021402
Approval Date: 24-JUL-02
Trade Name: SYNTHROID
Chemical Type: 5
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): LEVOTHYROXINE SODIUM
OTC/RX Status: RX
Indication of Use: HYPOTHYROIDISM, SUPPRESSION OF THYROID STIMULATING HORMONE

Original New Drug Application # 021379
Approval Date: 24-JUL-02
Trade Name: ELIGARD
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: ATRIX LABORATORIES INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX
Indication of Use: PALLIATIVE TREATMENT OF ADVANCE PROSTATE CANCER

Original New Drug Application # 021200
Approval Date: 24-JUL-02
Trade Name: ZELNORM
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): TEGASEROD MALEATE
OTC/RX Status: RX
Indication of Use: TREATMENT OF WOMEN WITH IRRITABLE BOWEL SYNDROME WHOSE PRIMARY BOWEL SYMPTOM IS CONSTIPATION

Original New Drug Application # 021196
Approval Date: 17-JUL-02
Trade Name: XYREM
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: SOLUTION
Applicant: ORPHAN MEDICAL INC
Active Ingredient(s): SODIUM OXYBATE
OTC/RX Status: RX
Indication of Use: Treatment to reduce the incidence of cataplexy in patients with narcolepsy. 

Original New Drug Application # 021282
Approval Date: 12-JUL-02
Trade Name: MUCINEX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET, CONTROLLED RELEASE
Applicant: ADAMS LABORATORIES INC
Active Ingredient(s): GUAIFENESIN
OTC/RX Status: RX
Indication of Use: For loosening phlegm/thin bronchial secretions in patients with chronic bronchitis

Efficacy Supplemental New Drug Applications

Application #: 020406 Efficacy Supplement #: 047
Type: SE5 to Original New Drug Application
Approval Date: 31-JUL-02
Trade Name: PREVACID
Dosage Form: CAPSULE
Applicant: TAP PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX
Efficacy Claim: FOR HEALING AND SYMTOM RELIEF OF ACTIVE DUODENAL ULCER

Application #: 018936 Efficacy Supplement #: 061
Type: SE1 to Original New Drug Application
Approval Date: 29-JUL-02
Trade Name: PROZAC
Dosage Form: CAPSULE
Applicant: LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: TREATMENT OF MAJOR DEPRESSIVE DISORDER

Application #: 020762 Efficacy Supplement #: 011
Type: SE5 to Original New Drug Application
Approval Date: 17-JUL-02
Trade Name: NASONEX
Dosage Form: SPRAY, METERED
Applicant: SCHERING PLOUGH CORP
Active Ingredient(s): MOMETASONE FUROATE MONOHYDRATE
OTC/RX Status: RX
Efficacy Claim: For the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis

Application #: 019796 Efficacy Supplement #: 015
Type: SE5 to Original New Drug Application
Approval Date: 17-JUL-02
Trade Name: ELOCON
Dosage Form: LOTION
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): MOMETASONE FUROATE
OTC/RX Status: RX
Efficacy Claim: For the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses

Application #: 019625 Efficacy Supplement #: 013
Type: SE5 to Original New Drug Application
Approval Date: 17-JUL-02
Trade Name: ELOCON
Dosage Form: CREAM
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): MOMETASONE FUROATE
OTC/RX Status: RX
Efficacy Claim: For the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses

Application #: 019543 Efficacy Supplement #: 013
Type: SE5 to Original New Drug Application
Approval Date: 17-JUL-02
Trade Name: ELOCON
Dosage Form: OINTMENT
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): MOMETASONE FUROATE
OTC/RX Status: RX
Efficacy Claim: For the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses

Application #: 019810 Efficacy Supplement #: 074
Type: SE5 to Original New Drug Application
Approval Date: 12-JUL-02
Trade Name: PRILOSEC
Dosage Form: CAPSULE, ENTERIC COATED PELLETS
Applicant: ASTRAZENECA LP
Active Ingredient(s): OMEPRAZOLE
OTC/RX Status: RX
Efficacy Claim: For short term treatment of active duodenal ulcer

Approvable Original New Drug Applications

Original Application #: 021339
Approvable Date: 19-JUL-02
Trade Name: PROCLIR
Dosage Form: TABLET
Applicant: MCNEIL CONSUMER AND SPECIALTY PHARMACEUTICALS DIV MCNEIL P CC INC
Active Ingredient(s): LORATADINE
OTC/RX Status: RX

Original Application #: 021375
Approvable Date: 03-JUL-02
Trade Name: ALAVERT
Dosage Form: TABLET, ORALLY DISINTEGRATING
Applicant: WYETH CONSUMER HEALTHCARE
Active Ingredient(s): LORATADINE
OTC/RX Status: OTC

Original Abbreviated New Drug Applications

Original Abbreviated Application # 076268
Approval Date: 26-JUL-02
Trade Name: DIGOXIN
Dosage Form: TABLET
Applicant: JEROME STEVENS PHARMACEUTICALS INC
Active Ingredient(s): DIGOXIN
OTC/RX Status: RX

Original Abbreviated Application # 075943
Approval Date: 26-JUL-02
Trade Name: ETODOLAC
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Original Abbreviated Application # 075867
Approval Date: 22-JUL-02
Trade Name: IPRATROPIUM BROMIDE
Dosage Form: SOLUTION
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): IPRATROPIUM BROMIDE
OTC/RX Status: RX

Original Abbreviated Application # 075857
Approval Date: 22-JUL-02
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 076283
Approval Date: 12-JUL-02
Trade Name: TIZANIDINE HCL
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): TIZANIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075974
Approval Date: 12-JUL-02
Trade Name: TRAMADOL HCL
Dosage Form: TABLET
Applicant: ASTA MEDICA INC
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075250
Approval Date: 12-JUL-02
Trade Name: PREDNISOLONE SODIUM PHOSPHATE
Dosage Form: SOLUTION
Applicant: WE PHARMACEUTICALS INC
Active Ingredient(s): PREDNISOLONE SODIUM PHOSPHATE
OTC/RX Status: RX

Original Abbreviated Application # 040256
Approval Date: 12-JUL-02
Trade Name: PREDNISONE
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): PREDNISONE
OTC/RX Status: RX

Original Abbreviated Application # 076095
Approval Date: 10-JUL-02
Trade Name: MISOPROSTOL
Dosage Form: TABLET
Applicant: IVAX PHARMACEUTICALS INC
Active Ingredient(s): MISOPROSTOL
OTC/RX Status: RX

Original Abbreviated Application # 075981
Approval Date: 10-JUL-02
Trade Name: TRAMADOL HCL
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075934
Approval Date: 09-JUL-02
Trade Name: NIZATIDINE
Dosage Form: CAPSULE
Applicant: GENPHARM INC
Active Ingredient(s): NIZATIDINE
OTC/RX Status: RX

Original Abbreviated Application # 075616
Approval Date: 09-JUL-02
Trade Name: NIZATIDINE
Dosage Form: CAPSULE
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): NIZATIDINE
OTC/RX Status: RX

Original Abbreviated Application # 040437
Approval Date: 09-JUL-02
Trade Name: EDETATE DISODIUM
Dosage Form: INJECTABLE
Applicant: DBA BIONICHE PHARMA CANADA LTD
Active Ingredient(s): EDETATE DISODIUM
OTC/RX Status: RX

Original Abbreviated Application # 076265
Approval Date: 08-JUL-02
Trade Name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: WEST WARD PHARMACEUTICAL CORP
Active Ingredient(s): HYDROCHLOROTHIAZIDE; LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 075593
Approval Date: 08-JUL-02
Trade Name: CIPROFLOXACIN
Dosage Form: TABLET
Applicant: DR REDDYS LABORATORIES INC
Active Ingredient(s): CIPROFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075461
Approval Date: 08-JUL-02
Trade Name: NIZATIDINE
Dosage Form: CAPSULE
Applicant: ZENITH GOLDLINE PHARM INC
Active Ingredient(s): NIZATIDINE
OTC/RX Status: RX

Original Abbreviated Application # 076178
Approval Date: 05-JUL-02
Trade Name: NIZATIDINE
Dosage Form: CAPSULE
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): NIZATIDINE
OTC/RX Status: RX

Original Abbreviated Application # 076051
Approval Date: 05-JUL-02
Trade Name: LABETALOL HCL
Dosage Form: INJECTABLE
Applicant: APOTEX CORP
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075806
Approval Date: 05-JUL-02
Trade Name: NIZATIDINE
Dosage Form: CAPSULE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): NIZATIDINE
OTC/RX Status: RX

Original Abbreviated Application # 076286
Approval Date: 03-JUL-02
Trade Name: TIZANIDINE HCL
Dosage Form: TABLET
Applicant: DR REDDYS LABORATORIES LTD
Active Ingredient(s): TIZANIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 076284
Approval Date: 03-JUL-02
Trade Name: TIZANIDINE HCL
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): TIZANIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075963
Approval Date: 03-JUL-02
Trade Name: TRAMADOL HCL
Dosage Form: TABLET
Applicant: ABLE LABORATORIES INC
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075849
Approval Date: 03-JUL-02
Trade Name: OXAPROZIN
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): OXAPROZIN
OTC/RX Status: RX

Original Abbreviated Application # 075895
Approval Date: 02-JUL-02
Trade Name: SEVOFLURANE
Dosage Form: LIQUID
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): SEVOFLURANE
OTC/RX Status: RX

Original Abbreviated Application # 076262
Approval Date: 01-JUL-02
Trade Name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 076230
Approval Date: 01-JUL-02
Trade Name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 076194
Approval Date: 01-JUL-02
Trade Name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 076180
Approval Date: 01-JUL-02
Trade Name: LISINOPRIL
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 076164
Approval Date: 01-JUL-02
Trade Name: LISINOPRIL
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 076113
Approval Date: 01-JUL-02
Trade Name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 076071
Approval Date: 01-JUL-02
Trade Name: LISINOPRIL
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 076063
Approval Date: 01-JUL-02
Trade Name: LISINOPRIL
Dosage Form: TABLET
Applicant: WEST WARD PHARMACEUTICAL CORP
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 076059
Approval Date: 01-JUL-02
Trade Name: LISINOPRIL
Dosage Form: TABLET
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 076007
Approval Date: 01-JUL-02
Trade Name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): HYDROCHLOROTHIAZIDE; LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 075999
Approval Date: 01-JUL-02
Trade Name: LISINOPRIL
Dosage Form: TABLET
Applicant: LEK PHARMACEUTICAL AND CHEMICAL CO
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 075994
Approval Date: 01-JUL-02
Trade Name: LISINOPRIL
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 075982
Approval Date: 01-JUL-02
Trade Name: TRAMADOL HCL
Dosage Form: TABLET
Applicant: SIDMAK LABORATORIES INC
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075944
Approval Date: 01-JUL-02
Trade Name: LISINOPRIL
Dosage Form: TABLET
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 075926
Approval Date: 01-JUL-02
Trade Name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS TECHNOLOGY CORP
Active Ingredient(s): HYDROCHLOROTHIAZIDE; LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 075869
Approval Date: 01-JUL-02
Trade Name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 075783
Approval Date: 01-JUL-02
Trade Name: LISINOPRIL
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 075776
Approval Date: 01-JUL-02
Trade Name: HYDROCHLOROTHIAZIDE AND LISINOPRIL
Dosage Form: TABLET
Applicant: IVAX PHARMACEUTICALS INC
Active Ingredient(s): LISINOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Original Abbreviated Application # 075743
Approval Date: 01-JUL-02
Trade Name: LISINOPRIL
Dosage Form: TABLET
Applicant: PAR PHARMACEUTICAL INC
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval

Original Abbreviated Application #: 075711
Tentative Approval Date: 24-JUL-02
Trade Name: ALENDRONATE SODIUM
Dosage Form: TABLET
Applicant: IVAX PHARMACEUTICALS INC
Active Ingredient(s): ALENDRONATE SODIUM
OTC/RX Status: RX

Original Abbreviated Application #: 076173
Tentative Approval Date: 17-JUL-02
Trade Name: RILUZOLE
Dosage Form: TABLET
Applicant: IMPAX LABORATORIES INC
Active Ingredient(s): RILUZOLE
OTC/RX Status: RX

Original Abbreviated Application #: 076179
Tentative Approval Date: 10-JUL-02
Trade Name: TAMOXIFEN CITRATE
Dosage Form: TABLET
Applicant: ANDRIX PHARMACEUTICALS INC
Active Ingredient(s): TAMOXIFEN CITRATE
OTC/RX Status: RX

Original Abbreviated Application #: 076171
Tentative Approval Date: 10-JUL-02
Trade Name: MOMETASONE FUROATE
Dosage Form: CREAM
Applicant: ALTANA INC
Active Ingredient(s): MOMETASONE FUROATE
OTC/RX Status: RX

Original Abbreviated Application #: 075706
Tentative Approval Date: 09-JUL-02
Trade Name: LORATADINE AND PSEUDOEPHEDRINE HCL
Dosage Form: TABLET
Applicant: ANDRX PHARMACEUTICALS INC
Active Ingredient(s): LORATADINE; PSEUDOEPHEDRINE SULFATE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 021076 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 31-JUL-02
Trade Name: ALEVE COLD AND SINUS
Dosage Form: TABLET
Applicant: BAYER CORP CONSUMER CARE DIV
Active Ingredient(s): NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
OTC/RX Status: OTC

Application #: 020148 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 31-JUL-02
Trade Name: MIGRANAL
Dosage Form: SPRAY, METERED
Applicant: XCEL PHARMACEUTICALS
Active Ingredient(s): DIHYDROERGOTAMINE MESYLATE
OTC/RX Status: RX

Application #: 020148 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 31-JUL-02
Trade Name: MIGRANAL
Dosage Form: SPRAY, METERED
Applicant: XCEL PHARMACEUTICALS
Active Ingredient(s): DIHYDROERGOTAMINE MESYLATE
OTC/RX Status: RX

Application #: 005929 Labeling Supplement #: 033
To Original New Drug Application
Approval Date: 31-JUL-02
Trade Name: D.H.E. 45
Dosage Form: INJECTABLE
Applicant: XCEL PHARMACEUTICALS
Active Ingredient(s): DIHYDROERGOTAMINE MESYLATE
OTC/RX Status: RX

Application #: 005929 Labeling Supplement #: 032
To Original New Drug Application
Approval Date: 31-JUL-02
Trade Name: D.H.E. 45
Dosage Form: INJECTABLE
Applicant: XCEL PHARMACEUTICALS
Active Ingredient(s): DIHYDROERGOTAMINE MESYLATE
OTC/RX Status: RX

Application #: 020449 Labeling Supplement #: 019
To Original New Drug Application
Approval Date: 30-JUL-02
Trade Name: TAXOTERE
Dosage Form: INJECTABLE
Applicant: AVENTIS PHARMACEUTICALS INC
Active Ingredient(s): DOCETAXEL
OTC/RX Status: RX

Application #: 017646 Labeling Supplement #: 049
To Original New Drug Application
Approval Date: 30-JUL-02
Trade Name: PERGONAL
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): FOLLITROPIN; LUTEINIZING HORMONE
OTC/RX Status: RX

Application #: 007073 Labeling Supplement #: 120
To Original New Drug Application
Approval Date: 30-JUL-02
Trade Name: AZULFIDINE
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): SULFASALAZINE
OTC/RX Status: RX

Application #: 016862 Labeling Supplement #: 033
To Original New Drug Application
Approval Date: 26-JUL-02
Trade Name: DARVON-N
Dosage Form: TABLET
Applicant: AAIPHARMA LLC
Active Ingredient(s): PROPOXYPHENE NAPSYLATE
OTC/RX Status: RX

Application #: 010997 Labeling Supplement #: 043
To Original New Drug Application
Approval Date: 26-JUL-02
Trade Name: DARVON
Dosage Form: CAPSULE
Applicant: AAI PHARMA LLC
Active Ingredient(s): PROPOXYPHENE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 010996 Labeling Supplement #: 061
To Original New Drug Application
Approval Date: 26-JUL-02
Trade Name: DARVON COMPOUND
Dosage Form: CAPSULE
Applicant: AAIPHARMA LLC
Active Ingredient(s): PROPOXYPHENE HYDROCHLORIDE; PHENACETIN; ASPIRIN ; CAFFEINE
OTC/RX Status: RX

Application #: 020734 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 25-JUL-02
Trade Name: CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): AMINO ACIDS; DEXTROSE
OTC/RX Status: RX

Application #: 020678 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 25-JUL-02
Trade Name: CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): AMINO ACIDS; DEXTROSE; POTASSIUM PHOSPHATE, DIB ASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; SODIUM ACETATE
OTC/RX Status: RX

Application #: 020560 Labeling Supplement #: 031
To Original New Drug Application
Approval Date: 25-JUL-02
Trade Name: FOSAMAX
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): ALENDRONATE SODIUM
OTC/RX Status: RX

Application #: 050739 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 24-JUL-02
Trade Name: OMNICEF
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): CEFDINIR
OTC/RX Status: RX

Application #: 050605 Labeling Supplement #: 037
To Original New Drug Application
Approval Date: 24-JUL-02
Trade Name: CEFTIN
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): CEFUROXIME AXETIL
OTC/RX Status: RX

Application #: 020913 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 24-JUL-02
Trade Name: AGGRASTAT
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): TIROFIBAN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020912 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 24-JUL-02
Trade Name: AGGRASTAT
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): TIROFIBAN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019667 Labeling Supplement #: 032
To Original New Drug Application
Approval Date: 24-JUL-02
Trade Name: SANDOSTATIN
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): OCTREOTIDE ACETATE
OTC/RX Status: RX

Application #: 019667 Labeling Supplement #: 028
To Original New Drug Application
Approval Date: 24-JUL-02
Trade Name: SANDOSTATIN
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): OCTREOTIDE ACETATE
OTC/RX Status: RX

Application #: 020536 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 23-JUL-02
Trade Name: NICOTROL
Dosage Form: PATCH, CONTROLLED RELEASE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): NICOTINE
OTC/RX Status: OTC

Application #: 017820 Labeling Supplement #: 037
To Original New Drug Application
Approval Date: 23-JUL-02
Trade Name: DOBUTREX
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): DOBUTAMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050733 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 22-JUL-02
Trade Name: ZITHROMAX
Dosage Form: POWDER
Applicant: PFIZER INC
Active Ingredient(s): AZITHROMYCIN DIHYDRATE
OTC/RX Status: RX

Application #: 050730 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 22-JUL-02
Trade Name: ZITHROMAX
Dosage Form: TABLET
Applicant: PFIZER CENTRAL RESEARCH
Active Ingredient(s): AZITHROMYCIN DIHYDRATE
OTC/RX Status: RX

Application #: 050711 Labeling Supplement #: 012
To Original New Drug Application
Approval Date: 22-JUL-02
Trade Name: ZITHROMAX
Dosage Form: TABLET
Applicant: PFIZER INC
Active Ingredient(s): AZITHROMYCIN DIHYDRATE
OTC/RX Status: RX

Application #: 050710 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 22-JUL-02
Trade Name: ZITHROMAX
Dosage Form: TABLET
Applicant: PFIZER CHEMICALS DIV PFIZER INC
Active Ingredient(s): AZITHROMYCIN DIHYDRATE
OTC/RX Status: RX

Application #: 050693 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 22-JUL-02
Trade Name: ZITHROMAX
Dosage Form: POWDER
Applicant: PFIZER CENTRAL RESEARCH
Active Ingredient(s): AZITHROMYCIN DIHYDRATE
OTC/RX Status: RX

Application #: 050670 Labeling Supplement #: 019
To Original New Drug Application
Approval Date: 22-JUL-02
Trade Name: ZITHROMAX
Dosage Form: CAPSULE
Applicant: PFIZER CHEMICALS DIV PFIZER INC
Active Ingredient(s): AZITHROMYCIN DIHYDRATE
OTC/RX Status: RX

Application #: 019885 Labeling Supplement #: 019
To Original New Drug Application
Approval Date: 22-JUL-02
Trade Name: ACCUPRIL
Dosage Form: TABLET
Applicant: PFIZER PHARMACEUTICALS LTD
Active Ingredient(s): QUINAPRIL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050504 Labeling Supplement #: 059
To Original New Drug Application
Approval Date: 18-JUL-02
Trade Name: MANDOL
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): CEFAMANDOLE NAFATE
OTC/RX Status: RX

Application #: 021301 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 17-JUL-02
Trade Name: LEVOXYL
Dosage Form: TABLET
Applicant: JONES PHARMA INC SUB KING PHARMACEUTICALS INC
Active Ingredient(s): LEVOTHYROXINE SODIUM
OTC/RX Status: RX

Application #: 020966 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 17-JUL-02
Trade Name: SPORANOX
Dosage Form: INJECTION
Applicant: JANSSEN PHARMACEUTICA PRODUCTS LP
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX

Application #: 020657 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 17-JUL-02
Trade Name: SPORANOX
Dosage Form: SOLUTION
Applicant: JANSSEN PHARMACEUTICA PRODUCTS LP
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX

Application #: 020083 Labeling Supplement #: 028
To Original New Drug Application
Approval Date: 17-JUL-02
Trade Name: SPORANOX
Dosage Form: CAPSULE
Applicant: JANSSEN PHARMACEUTICA PRODUCTS LP
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX

Application #: 019796 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 17-JUL-02
Trade Name: ELOCON
Dosage Form: LOTION
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): MOMETASONE FUROATE
OTC/RX Status: RX

Application #: 019625 Labeling Supplement #: 012
To Original New Drug Application
Approval Date: 17-JUL-02
Trade Name: ELOCON
Dosage Form: CREAM
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): MOMETASONE FUROATE
OTC/RX Status: RX

Application #: 019543 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 17-JUL-02
Trade Name: ELOCON
Dosage Form: OINTMENT
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): MOMETASONE FUROATE
OTC/RX Status: RX

Application #: 018519 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 17-JUL-02
Trade Name: IRRIGATING SOLUTION G IN PLASTIC CONTAINER
Dosage Form: SOLUTION
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): CITRIC ACID; SODIUM CARBONATE; MAGNESIUM OXIDE
OTC/RX Status: RX

Application #: 017865 Labeling Supplement #: 038
To Original New Drug Application
Approval Date: 17-JUL-02
Trade Name: AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER
Dosage Form: SOLUTION
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): GLYCINE
OTC/RX Status: RX

Application #: 016084 Labeling Supplement #: 041
To Original New Drug Application
Approval Date: 17-JUL-02
Trade Name: ZYLOPRIM
Dosage Form: TABLET
Applicant: PROMETHEUS LABORATORIES INC
Active Ingredient(s): ALLOPURINOL
OTC/RX Status: RX

Application #: 020076 Labeling Supplement #: 021
To Original New Drug Application
Approval Date: 15-JUL-02
Trade Name: HABITROL
Dosage Form: FILM, EXTENDED RELEASE
Applicant: NOVARTIS CONSUMER HEALTH INC
Active Ingredient(s): NICOTINE
OTC/RX Status: RX

Application #: 050615 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 14-JUL-02
Trade Name: CLEOCIN T
Dosage Form: GEL
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX

Application #: 050600 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 14-JUL-02
Trade Name: CLEOCIN T
Dosage Form: LOTION
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX

Application #: 050537 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 14-JUL-02
Trade Name: CLEOCIN T
Dosage Form: SWAB
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX

Application #: 021108 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 14-JUL-02
Trade Name: RENOVA
Dosage Form: CREAM
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 020076 Labeling Supplement #: 020
To Original New Drug Application
Approval Date: 12-JUL-02
Trade Name: HABITROL
Dosage Form: FILM, EXTENDED RELEASE
Applicant: NOVARTIS CONSUMER HEALTH INC
Active Ingredient(s): NICOTINE
OTC/RX Status: RX

Application #: 019898 Labeling Supplement #: 050
To Original New Drug Application
Approval Date: 12-JUL-02
Trade Name: PRAVACHOL
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): PRAVASTATIN SODIUM
OTC/RX Status: RX

Application #: 020918 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 11-JUL-02
Trade Name: GLUCAGEN
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICALS INC
Active Ingredient(s): GLUCAGON HYDROCHLORIDE RECOMBINANT
OTC/RX Status: RX

Application #: 020449 Labeling Supplement #: 017
To Original New Drug Application
Approval Date: 09-JUL-02
Trade Name: TAXOTERE
Dosage Form: INJECTABLE
Applicant: AVENTIS PHARMACEUTICALS INC
Active Ingredient(s): DOCETAXEL
OTC/RX Status: RX

Application #: 018920 Labeling Supplement #: 024
To Original New Drug Application
Approval Date: 09-JUL-02
Trade Name: M.V.I. PEDIATRIC
Dosage Form: INJECTABLE
Applicant: NEOSAN PHARMACEUTICALS
Active Ingredient(s): ASCORBIC ACID; VITAMIN A; ERGOCALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; DEXPANTHENOL; VITAMIN E; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; PHYTONADIONE; NIACINAMIDE
OTC/RX Status: RX

Application #: 018154 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 09-JUL-02
Trade Name: LONITEN
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): MINOXIDIL
OTC/RX Status: RX

Application #: 021064 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 08-JUL-02
Trade Name: DEFINITY
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB MEDICAL IMAGING
Active Ingredient(s): PERFLUTREN
OTC/RX Status: RX

Application #: 020652 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 08-JUL-02
Trade Name: TESLASCAN
Dosage Form: INJECTABLE
Applicant: AMERSHAM HEALTH
Active Ingredient(s): MANGAFODIPIR TRISODIUM
OTC/RX Status: RX

Application #: 020123 Labeling Supplement #: 018
To Original New Drug Application
Approval Date: 08-JUL-02
Trade Name: OMNISCAN
Dosage Form: INJECTABLE
Applicant: AMERSHAM HEALTH
Active Ingredient(s): GADODIAMIDE
OTC/RX Status: RX

Application #: 018735 Labeling Supplement #: 043
To Original New Drug Application
Approval Date: 08-JUL-02
Trade Name: ISOVUE-M
Dosage Form: INJECTABLE
Applicant: BRACCO DIAGNOSTICS INC
Active Ingredient(s): IOPAMIDOL
OTC/RX Status: RX

Application #: 017351 Labeling Supplement #: 027
To Original New Drug Application
Approval Date: 08-JUL-02
Trade Name: CORTIFOAM
Dosage Form: AEROSOL, METERED
Applicant: SCHWARZ PHARMA INC
Active Ingredient(s): HYDROCORTISONE ACETATE
OTC/RX Status: RX

Application #: 019758 Labeling Supplement #: 048
To Original New Drug Application
Approval Date: 05-JUL-02
Trade Name: CLOZARIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CLOZAPINE
OTC/RX Status: RX

Application #: 020199 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 03-JUL-02
Trade Name: HIVID
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): ZALCITABINE
OTC/RX Status: RX

Application #: 017863 Labeling Supplement #: 040
To Original New Drug Application
Approval Date: 03-JUL-02
Trade Name: SORBITOL 3% IN PLASTIC CONTAINER
Dosage Form: SOLUTION
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): SORBITOL
OTC/RX Status: RX

Application #: 020828 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 02-JUL-02
Trade Name: FORTOVASE
Dosage Form: CAPSULE
Applicant: HLR TECHNOLOGY
Active Ingredient(s): SAQUINAVIR
OTC/RX Status: RX

Application #: 020628 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 02-JUL-02
Trade Name: INVIRASE
Dosage Form: CAPSULE
Applicant: HLR TECHNOLOGY
Active Ingredient(s): SAQUINAVIR MESYLATE
OTC/RX Status: RX