Drug Approvals for August 1999

Definitions and Notes

Original New Drug Applications

Original Application #: 020984
Approval Date: 18-AUG-99
Trade Name: RAPLON
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: ORGANON INC SUB AKZO NOBEL INC
Active Ingredient(s): RAPACURONIUM BROMIDE
OTC/RX Status: RX
Indication(s): For outpatients and inpatients as an adjunct to general anesthesia to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgical procedures

Original Application #: 050767
Approval Date: 13-AUG-99
Trade Name: CLEOCIN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SUPPOSITORY
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX
Indication(s): For the treatment of bacterial vaginosis

Original Application #: 020859
Approval Date: 13-AUG-99
Trade Name: SONATA
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ZALEPLON
OTC/RX Status: RX
Indication(s): For the short-term treatment of insomnia

Original Application #: 021029
Approval Date: 11-AUG-99
Trade Name: TEMODAR
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: CAPSULE
Applicant: SCHERING CORP
Active Ingredient(s): TEMOZOLOMIDE
OTC/RX Status: RX
Indication(s): For the treatment of adult patients with refractory anaplastic astrocytoma, ie., patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine.

Original Application #: 020997
Approval Date: 05-AUG-99
Trade Name: CHIROCAINE
Chemical Type: 2
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: DARWIN DISCOVERY LTD
Active Ingredient(s): LEVOBUPIVACAINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For surgical anesthesia and pain management for adults

Original Application #: 020902
Approval Date: 05-AUG-99
Trade Name: PEPCID AC
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: OTC
Indication(s): For the treatment or prevention of meal-induced heartburn associated with acid indigestion and sour stomach

Original Application #: 021012
Approval Date: 03-AUG-99
Trade Name: NEOTECT
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: DIATIDE INC
Active Ingredient(s): TECHNETIUM TC-99M DEPREOTIDE
OTC/RX Status: RX
Indication(s): For patients presenting with pulmonary lesions on computed tomography and/or chest x-ray who have known malignancy or who are highly suspect for malignancy

Efficacy Supplemental New Drug Applications

Application #: 020103 Efficacy Supplement#: 015
Type: SE1 to Original New Drug Application
Approval Date: 27-AUG-99
Trade Name: ZOFRAN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ONDANSETRON HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin

Application #: 050479 Efficacy Supplement#: 015
Type: SE8 to Original New Drug Application
Approval Date: 26-AUG-99
Trade Name: CORTISPORIN
Dosage Form: SOLUTION
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): NEOMYCIN; POLYMYXIN B SULFATE; HYDROCORTISONE
OTC/RX Status: RX
Efficacy Claim: For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics

Application #: 050605 Efficacy Supplement#: 032
Type: SE8 to Original New Drug Application
Approval Date: 24-AUG-99
Trade Name: CEFTIN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME AXETIL
OTC/RX Status: RX
Efficacy Claim: For the treatment of acute bacterial maxillary sinusitis in pediatric patents

Application #: 019452 Efficacy Supplement#: 015
Type: SE1 to Original New Drug Application
Approval Date: 18-AUG-99
Trade Name: DERMA-SMOOTHE/FS
Dosage Form: OIL
Applicant: HILL DERMACEUTICALS INC
Active Ingredient(s): FLUOCINOLONE ACETONIDE
OTC/RX Status: RX
Efficacy Claim: For the treatment of atopic dermatitis in pediatric patients 6 years of age or older

Application #: 020682 Efficacy Supplement#: 001
Type: SE8 to Original New Drug Application
Approval Date: 16-AUG-99
Trade Name: GLYSET
Dosage Form: TABLET
Applicant: PHARMACIA & UPJOHN
Active Ingredient(s): MIGLITOL
OTC/RX Status: RX
Efficacy Claim: For use in the management of non-insulin-dependent diabetes mellitus (NIDDM)

Application #: 020482 Efficacy Supplement#: 010
Type: SE8 to Original New Drug Application
Approval Date: 16-AUG-99
Trade Name: PRECOSE
Dosage Form: TABLET
Applicant: BAYER CORPORATION
Active Ingredient(s): ACARBOSE
OTC/RX Status: RX
Efficacy Claim: For use in the management of type II diabetes mellitus

Application #: 019766 Efficacy Supplement#: 032
Type: SE1 to Original New Drug Application
Approval Date: 05-AUG-99
Trade Name: ZOCOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): SIMVASTATIN
OTC/RX Status: RX
Efficacy Claim: For the additional indication of increasing HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb).

Approvable Original New Drug Applications

Original Application #: 021037
Approvable Date: 26-AUG-99
Trade Name: MAGNEVIST
Dosage Form: INJECTABLE
Applicant: BERLEX LABORATORIES INC
Active Ingredient(s): GADOPENTETATE DIMEGLUMINE
OTC/RX Status: RX

Original Application #: 020989
Approvable Date: 27-AUG-99
Trade Name: EVOXAC
Dosage Form: CAPSULE
Applicant: SNOWBRAND PHARMACEUTICALS INC
Active Ingredient(s): CEVIMELINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075528
Approval Date: 30-AUG-99
Trade Name: CLOMIPHENE CITRATE
Dosage Form: TABLET
Applicant: PAR PHARMACEUTICAL INC
Active Ingredient(s): CLOMIPHENE CITRATE
OTC/RX Status: RX

Original Abbreviated Application # 075371
Approval Date: 27-AUG-99
Trade Name: DACARBAZINE
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): DACARBAZINE
OTC/RX Status: RX

Original Abbreviated Application # 074688
Approval Date: 25-AUG-99
Trade Name: VECURONIUM BROMIDE
Dosage Form: INJECTABLE
Applicant: GENSIA LABORATORIES LTD
Active Ingredient(s): VECURONIUM BROMIDE
OTC/RX Status: RX

Original Abbreviated Application # 040032
Approval Date: 17-AUG-99
Trade Name: CYCLOPHOSPHAMIDE
Dosage Form: TABLET
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): CYCLOPHOSPHAMIDE
OTC/RX Status: RX

Original Abbreviated Application # 040032
Approval Date: 17-AUG-99
Trade Name: CYCLOPHOSPHAMIDE
Dosage Form: TABLET
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): CYCLOPHOSPHAMIDE
OTC/RX Status: RX

Original Abbreviated Application # 075256
Approval Date: 12-AUG-99
Trade Name: DESOGESTREL AND ETHINYL ESTRADIOL
Dosage Form: TABLET
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): DESOGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Original Abbreviated Application # 075093
Approval Date: 10-AUG-99
Trade Name: PENTOXIFYLLINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: IMPAX PHARMACEUTICALS
Active Ingredient(s): PENTOXIFYLLINE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075405
Tentative Approval Date: 31-AUG-99
Trade Name: CLADRIBINE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): CLADRIBINE
OTC/RX Status: RX

Original Abbreviated Application #: 075324
Tentative Approval Date: 31-AUG-99
Trade Name: MIDAZOLAM HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: BAXTER PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075243
Tentative Approval Date: 31-AUG-99
Trade Name: MIDAZOLAM HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: ESI LEDERLE INC
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075490
Tentative Approval Date: 30-AUG-99
Trade Name: DOXAZOSIN MESYLATE
Dosage Form: TABLET
Applicant: ESI LEDERLE INC
Active Ingredient(s): DOXAZOSIN MESYLATE
OTC/RX Status: RX

Original Abbreviated Application #: 075302
Tentative Approval Date: 30-AUG-99
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 075461
Tentative Approval Date: 26-AUG-99
Trade Name: NIZATIDINE
Dosage Form: CAPSULE
Applicant: ZENITH GOLDLINE
Active Ingredient(s): NIZATIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 075476
Tentative Approval Date: 20-AUG-99
Trade Name: CARTEOLOL HCL
Dosage Form: SOLUTION
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): CARTEOLOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 074657
Tentative Approval Date: 20-AUG-99
Trade Name: TERAZOSIN HCL
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): TERAZOSIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075132
Tentative Approval Date: 11-AUG-99
Trade Name: RANITIDINE HCL
Dosage Form: TABLET
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: OTC

Labeling Supplements to Original New Drug Applications

Application #: 020766 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 31-AUG-99
Trade Name: XENICAL
Dosage Form: CAPSULE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): ORLISTAT
OTC/RX Status: RX

Application #:018985 Labeling Supplement#: 033
To Original New Drug Application
Approval Date: 27-AUG-99
Trade Name: ORTHO-NOVUM 7/7/7-21
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 018985 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 27-AUG-99
Trade Name: ORTHO-NOVUM 7/7/7-21
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 018985 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 27-AUG-99
Trade Name: ORTHO-NOVUM 7/7/7-21
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 018354 Labeling Supplement#: 037
To Original New Drug Application
Approval Date: 27-AUG-99
Trade Name: ORTHO-NOVUM 10/11-21
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 018354 Labeling Supplement#: 034
To Original New Drug Application
Approval Date: 27-AUG-99
Trade Name: ORTHO-NOVUM 10/11-21
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 017919 Labeling Supplement#: 069
To Original New Drug Application
Approval Date: 27-AUG-99
Trade Name: ORTHO-NOVUM 1/35 28
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 017919 Labeling Supplement#: 065
To Original New Drug Application
Approval Date: 27-AUG-99
Trade Name: ORTHO-NOVUM 1/35 28
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 017735 Labeling Supplement#: 087
To Original New Drug Application
Approval Date: 27-AUG-99
Trade Name: MODICON 28
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 017735 Labeling Supplement#: 083
To Original New Drug Application
Approval Date: 27-AUG-99
Trade Name: MODICON 28
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 017489 Labeling Supplement#: 087
To Original New Drug Application
Approval Date: 27-AUG-99
Trade Name: ORTHO-NOVUM 1/35 21
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 017489 Labeling Supplement#: 084
To Original New Drug Application
Approval Date: 27-AUG-99
Trade Name: ORTHO-NOVUM 1/35 21
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 017488 Labeling Supplement#: 104
To Original New Drug Application
Approval Date: 27-AUG-99
Trade Name: MODICON 21
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 017488 Labeling Supplement#: 101
To Original New Drug Application
Approval Date: 27-AUG-99
Trade Name: MODICON 21
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 019030 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 26-AUG-99
Trade Name: BRETYLIUM TOSYLATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): BRETYLIUM TOSYLATE
OTC/RX Status: RX

Application #: 019030 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 26-AUG-99
Trade Name: BRETYLIUM TOSYLATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): BRETYLIUM TOSYLATE
OTC/RX Status: RX

Application #: 019030 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 26-AUG-99
Trade Name: BRETYLIUM TOSYLATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): BRETYLIUM TOSYLATE
OTC/RX Status: RX

Application #: 018388 Labeling Supplement#: 067
To Original New Drug Application
Approval Date: 26-AUG-99
Trade Name: LIDOCAINE HCL 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): LIDOCAINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018388 Labeling Supplement#: 064
To Original New Drug Application
Approval Date: 26-AUG-99
Trade Name: LIDOCAINE HCL 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): LIDOCAINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 014103 Labeling Supplement#: 060
To Original New Drug Application
Approval Date: 26-AUG-99
Trade Name: ONCOVIN
Dosage Form:INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): VINCRISTINE SULFATE
OTC/RX Status: RX

Application #: 050443 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 25-AUG-99
Trade Name: BLENOXANE
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): BLEOMYCIN SULFATE
OTC/RX Status: RX

Application #: 009175 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 25-AUG-99
Trade Name: FURADANTIN
Dosage Form: SUSPENSION
Applicant: DURA PHARMACEUTICALS INC
Active Ingredient(s): NITROFURANTOIN
OTC/RX Status: RX

Application #: 020062 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 24-AUG-99
Trade Name: CARDIZEM CD
Dosage Form: CAPSULE
Applicant: MARION MERREL DOW
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018911 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 24-AUG-99
Trade Name: HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX

Application #: 016118 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 24-AUG-99
Trade Name: TESLAC
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): TESTOLACTONE
OTC/RX Status: RX

Application #: 019865 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 23-AUG-99
Trade Name: BETAPACE
Dosage Form: TABLET
Applicant: BERLEX LABORATORIES INC
Active Ingredient(s): SOTALOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 016418 Labeling Supplement#: 071
To Original New Drug Application
Approval Date: 22-AUG-99
Trade Name: INDERAL
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): PROPRANOLOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018553 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 22-AUG-99
Trade Name: INDERAL LA
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): PROPRANOLOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 016419 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 22-AUG-99
Trade Name: INDERAL
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): PROPRANOLOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 016016 Labeling Supplement#: 070
To Original New Drug Application
Approval Date: 22-AUG-99
Trade Name: ALDOCLOR
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): METHYLDOPA; CHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 018917 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 22-AUG-99
Trade Name: SECTRAL
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ACEBUTOLOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018554 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 19-AUG-99
Trade Name: EULEXIN
Dosage Form: CAPSULE
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): FLUTAMIDE
OTC/RX Status: RX

Application #: 012750 Labeling Supplement#: 057
To Original New Drug Application
Permitted Date: 17-AUG-99
Trade Name: LIBRAX
Dosage Form: CAPSULE
Applicant: ICN PUERTO RICO INC
Active Ingredient(s): CLIDINIUM BROMIDE; CHLORDIAZEPOXIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 007409 Labeling Supplement#: 039
To Original New Drug Application
Approval Date: 17-AUG-99
Trade Name: BENTYL
Dosage Form: TABLET
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): DICYCLOMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 008370 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 17-AUG-99
Trade Name: BENTYL
Dosage Form: INJECTABLE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): DICYCLOMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 007961 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 17-AUG-99
Trade Name: BENTYL
Dosage Form: SYRUP
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): DICYCLOMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020705 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 16-AUG-99
Trade Name: RESCRIPTOR
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): DELAVIRDINE MESYLATE
OTC/RX Status: RX

Application #: 019617 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 13-AUG-99
Trade Name: PREPIDIL
Dosage Form: GEL
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): DINOPROSTONE
OTC/RX Status: RX

Application #: 017386 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 13-AUG-99
Trade Name: ZAROXOLYN
Dosage Form: TABLET
Applicant: MEDEVA PHARMACEUTICALS INC
Active Ingredient(s): METOLAZONE
OTC/RX Status: RX

Application #: 007073 Labeling Supplement#: 110
To Original New Drug Application
Approval Date: 13-AUG-99
Trade Name: AZULFIDINE
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): SULFASALAZINE
OTC/RX Status: RX

Application #: 007073 Labeling Supplement#: 110
To Original New Drug Application
Approval Date: 13-AUG-99
Trade Name: AZULFIDINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): SULFASALAZINE
OTC/RX Status: RX

Application #: 050734 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 12-AUG-99
Trade Name: IDAMYCIN PFS
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): IDARUBICIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 016295 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 11-AUG-99
Trade Name: HYDREA
Dosage Form: CAPSULE
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): HYDROXYUREA
OTC/RX Status: RX

Application #: 017943 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 06-AUG-99
Trade Name: PROLOPRIM
Dosage Form: TABLET
Applicant: MONARCH PHARMACEUTICALS INC
Active Ingredient(s): TRIMETHOPRIM
OTC/RX Status: RX

Application #: 050588 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 05-AUG-99
Trade Name: CEFOTAN
Dosage Form: INJECTABLE
Applicant: ZENECA INC
Active Ingredient(s): CEFOTETAN DISODIUM
OTC/RX Status: RX

Application #: 018651 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 05-AUG-99
Trade Name: MARINOL
Dosage Form: CAPSULE
Applicant: UNIMED INC
Active Ingredient(s): DRONABINOL
OTC/RX Status: RX

Application #:020180 Labeling Supplement#:018 To Original New Drug Application
Approval Date: 02-AUG-99
Trade Name: PROSCAR
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): FINASTERIDE
OTC/RX Status: RX

Application #:019591Labeling Supplement#:012 To Original New Drug Application
Approval Date: 02-AUG-99
Trade Name: LARIAM
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): MEFLOQUINE HYDROCHLORIDE
OTC/RX Status: RX

Application #:019591Labeling Supplement#:010 To Original New Drug Application
Approval Date: 02-AUG-99
Trade Name: LARIAM
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): MEFLOQUINE HYDROCHLORIDE
OTC/RX Status: RX