Drug Approvals for November 2001

Definitions and Notes

Original New Drug Applications

Original Application #: 021277
Approval Date: 30-NOV-01
Trade Name: AVELOX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: BAYER CORP PHARMACEUTICAL DIV
Active Ingredient(s): MOXIFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the treatment of adults (greater or equal to 18 years of age) with infections caused by susceptible strains of the designated microorganisms in the following conditions: Acute Bacterial Sinusitis, Acute Bacterial Exacerbation of Chronic Bronchitis, Community Acquired Pneumonia, Uncomplicated Skin/Skin Structure Infections

Original Application #: 021278
Approval Date: 13-NOV-01
Trade Name: FOCALIN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: COLGENE CORPORATION
Active Ingredient(s): DEXMETHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Original Application #: 021319
Approval Date: 20-NOV-01
Trade Name: DUTASTERIDE
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s):DUTASTERIDE
OTC/RX Status: RX
Indication(s): For the treatment of symptomatic benign prostatic hyperplasia In men with an enlarged prostate gland

Original Application #: 021006
Approval Date: 08-NOV-01
Trade Name:FROVA
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ELAN PHARMA INTERNATIONAL LTD
Active Ingredient(s): FROVATRIPTAN SUCCINATE
OTC/RX Status: RX
Indication(s): For the acute treatment of migraine

Original Application #: 021268
Approval Date: 01-NOV-01
Trade Name: TEVETEN HCT
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: UNIMED PHARMACEUTICALS INC
Active Ingredient(s): EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX
Indication(s): For the treatment of hypertension

Original Application #: 021172
Approval Date: 01-NOV-01
Trade Name: NOVOLOG MIX 70/30
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICALS INC
Active Ingredient(s): INSULIN ASPART RECOMBINANT
OTC/RX Status: RX
Indication(s): For the treatment of patients with diabetes mellitus for the control of hyperglycemia

Efficacy Supplemental New Drug Applications

Application #: 020297 Efficacy Supplement#: 007
Type: SE1 to Original New Drug Application
Approval Date: 01-NOV-01
Trade Name: COREG
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): CARVEDILOL
OTC/RX Status: RX
Efficacy Claim: For severe heart failure

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075840
Approval Date: 30-NOV-01
Trade Name: NORGESTREL AND ETHINYL ESTRADIOL
Dosage Form: TABLET
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): NORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Original Abbreviated Application # 075829
Approval Date: 30-NOV-01
Trade Name: ETODOLAC
Dosage Form: TABLET
Applicant: ANDRX PHARMACEUTICALS INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Original Abbreviated Application # 075231
Approval Date: 30-NOV-01
Trade Name: BUTALBITAL ASPIRIN CAFFEINE AND CODEINE
Dosage Form: CAPSULE
Applicant: ANABOLIC INC
Active Ingredient(s): ASPIRIN; CAFFEINE; BUTALBITAL
OTC/RX Status: RX

Original Abbreviated Application # 075721
Approval Date: 29-NOV-01
Trade Name: LEUPROLIDE ACETATE
Dosage Form: INJECTABLE
Applicant: GENZYME CORP
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX

Original Abbreviated Application # 075998
Approval Date: 29-NOV-01
Trade Name: PROPAFENONE HCL
Dosage Form: TABLET
Applicant: MUTUAL PHARMACEUTICAL CO INC
Active Ingredient(s): PROPAFENONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075404
Approval Date: 28-NOV-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: DANBURY PHARMACAL INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: OTC

Original Abbreviated Application # 076057
Approval Date: 26-NOV-01
Trade Name: ETHAMBUTOL HCL
Dosage Form: TABLET
Applicant: BARR LABORATORIES INC
Active Ingredient(s): ETHAMBUTOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075794
Approval Date: 26-NOV-01
Trade Name: ACETAMINOPHEN, ASPIRIN AND CAFFEINE
Dosage Form: TABLET
Applicant: L PERRIGO CO
Active Ingredient(s): CAFFEINE; ACETAMINOPHEN; ASPIRIN
OTC/RX Status:

Original Abbreviated Application # 075507
Approval Date: 26-NOV-01
Trade Name:IPRATROPIUM
Dosage Form: SOLUTION
Applicant: WARRICK PHARMACEUTICALS
Active Ingredient(s): IPRATROPIUM
OTC/RX Status: RX

Original Abbreviated Application # 075905
Approval Date: 23-NOV-01
Trade Name:FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application # 075870
Approval Date: 23-NOV-01
Trade Name:FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application # 040434
Approval Date: 23-NOV-01
Trade Name:PERCOCET
Dosage Form: TABLET
Applicant: ENDO PHARMACEUTICALS
Active Ingredient(s): OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
OTC/RX Status: RX

Original Abbreviated Application # 075915
Approval Date: 21-NOV-2001
Trade Name: TIOCONAZOLE
Dosage Form: OINTMENT
Applicant: L. PERRIGO COMPANY
Active Ingredient(s): TIOCONAZOLE
OTC/RX Status: RX

Original Abbreviated Application # 075569
Approval Date: 21-NOV-01
Trade Name:THALLOUS CHLORIDE
Dosage Form: INJECTABLE
Applicant: MOUNT SANAI MEDICAL CENTER
Active Ingredient(s): THALLOUS CHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075749
Approval Date: 21-NOV-01
Trade Name:DILTIAZEM HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: INTERNATIONAL MEDICATION SYSTEMS, LIMITED
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 065034
Approval Date: 20-NOV-01
Trade Name: DAUNORUBICIN HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant:SUPERGEN, INC
Active Ingredient(s):DAUNORUBICIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 076117
Approval Date: 20-NOV-01
Trade Name:IBUPROFEN
Dosage Form: TABLET
Applicant: DR. REDDY'S LABORATORIES LIMITED
Active Ingredient(s): IBUPROFEN
OTC/RX Status: RX

Original Abbreviated Application # 075347
Approval Date: 16-NOV-01
Trade Name:OMEPRAZOLE
Dosage Form: CAPSULE
Applicant: ANDRX PHARMACEUTICALS, INC
Active Ingredient(s): OMEPRAZOLE
OTC/RX Status: RX

Original Abbreviated Application # 075682
Approval Date: 14-NOV-01
Trade Name:IBU
Dosage Form: TABLET
Applicant: BASF CORPORATION
Active Ingredient(s): IBUPROFEN
OTC/RX Status: RX

Original Abbreviated Application # 075916
Approval Date: 02-NOV-01
Trade Name: RIMANTADINE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: COREPHARMA, LLC
Active Ingredient(s):RIMANTADINE HYDROCHLORIDE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075863
Tentative Approval Date: 29-NOV-01
Trade Name: DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Dosage Form: TABLET
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): DESOGESTREL; ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
OTC/RX Status: RX

Original Abbreviated Application #: 075594
Tentative Approval Date: 28-NOV-01
Trade Name: PAMIDRONATE DISODIUM
Dosage Form: INJECTABLE
Applicant: AESGEN INC
Active Ingredient(s): PAMIDRONATE DISODIUM
OTC/RX Status: RX

Original Abbreviated Application #: 076182
Tentative Approval Date: 23-NOV-01
Trade Name: OFLOXACIN
Dosage Form: TABLET
Applicant: PHILIP ERICKSON
Active Ingredient(s): OFLOXACIN
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 050630 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 30-NOV-01
Trade Name: PRIMAXIN
Dosage Form: INJECTABLE
Applicant: MERCK AND CO INC
Active Ingredient(s): IMIPENEM; CILASTATIN SODIUM
OTC/RX Status: RX

Application #: 050587 Labeling Supplement#: 053
To Original New Drug Application
Approval Date: 30-NOV-01
Trade Name: PRIMAXIN
Dosage Form: INJECTABLE
Applicant: MERCK AND CO INC
Active Ingredient(s): IMIPENEM; CILASTATIN SODIUM
OTC/RX Status: RX

Application #: 018086 Labeling Supplement#: 056
To Original New Drug Application
Approval Date: 30-NOV-01
Trade Name: TIMOPTIC
Dosage Form: SOLUTION, DROPS
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX

Application #: 021093 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 28-NOV-01
Trade Name: ATACAND HCT
Dosage Form: TABLET
Applicant: ASTRAZENECA PHARMACEUTICALS LP
Active Ingredient(s): CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 020838 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 28-NOV-01
Trade Name: ATACAND
Dosage Form: TABLET
Applicant: ASTRAZENECA PHARMACEUTICALS LP
Active Ingredient(s): CANDESARTAN CILEXETIL
OTC/RX Status: RX

Application #: 019309 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 27-NOV-01
Trade Name: VASOTEC
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): ENALAPRILAT
OTC/RX Status: RX

Application #: 019221 Labeling Supplement #: 026
To Original New Drug Application
Approval Date: 27-NOV-01
Trade Name: VASERETIC
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 018998 Labeling Supplement #: 058
To Original New Drug Application
Approval Date: 27-NOV-01
Trade Name: VASOTEC
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): ENALAPRIL MALEATE
OTC/RX Status: RX

Application #: 018587 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 27-NOV-01
Trade Name: WYTENSIN
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): GUANABENZ ACETATE
OTC/RX Status: RX

Application #: 018421 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 26-NOV-01
Trade Name: LITHIUM CITRATE
Dosage Form: SYRUP
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): LITHIUM CITRATE
OTC/RX Status: RX

Application #: 018421 Labeling Supplement #: 015
To Original New Drug Application
Approval Date: 26-NOV-01
Trade Name: LITHIUM CITRATE
Dosage Form: SYRUP
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): LITHIUM CITRATE
OTC/RX Status: RX

Application #: 018421 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 26-NOV-01
Trade Name: LITHIUM CITRATE
Dosage Form: SYRUP
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): LITHIUM CITRATE
OTC/RX Status: RX

Application #: 018421 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 26-NOV-01
Trade Name: LITHIUM CITRATE
Dosage Form: SYRUP
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): LITHIUM CITRATE
OTC/RX Status: RX

Application #: 017812 Labeling Supplement #: 017
To Original New Drug Application
Approval Date: 26-NOV-01
Trade Name: LITHIUM CARBONATE
Dosage Form: CAPSULE
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX

Application #: 017812 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 26-NOV-01
Trade Name: LITHIUM CARBONATE
Dosage Form: CAPSULE
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX

Application #: 017812 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 26-NOV-01
Trade Name: LITHIUM CARBONATE
Dosage Form: CAPSULE
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX

Application #: 017812 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 26-NOV-01
Trade Name: LITHIUM CARBONATE
Dosage Form: CAPSULE
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX

Application #: 017812 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 26-NOV-01
Trade Name: LITHIUM CARBONATE
Dosage Form: CAPSULE
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX

Application #: 018332 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 26-NOV-01
Trade Name: INDOCIN
Dosage Form: SUSPENSION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): INDOMETHACIN
OTC/RX Status: RX

Application #: 016796 Labeling Supplement #: 039
To Original New Drug Application
Approval Date: 26-NOV-01
Trade Name: INAPSINE
Dosage Form: INJECTABLE
Applicant: AKORN INC
Active Ingredient(s): DROPERIDOL
OTC/RX Status: RX

Application #: 020849 Labeling Supplement #: 004
To Original New Drug Application
Approval Date: 14-NOV-01
Trade Name: PROSOL 20% SULFITE FREE
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV
Active Ingredient(s): AMINO ACIDS
OTC/RX Status: RX

Application #: 020708 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 14-NOV-01
Trade Name: LUPRON DEPOT-3
Dosage Form: SUSPENSION
Applicant: TAP PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX

Application #: 020011 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 14-NOV-01
Trade Name: LUPRON DEPOT
Dosage Form: INJECTABLE
Applicant: TAP PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX

Application #: 019943 Labeling Supplement #: 015
To Original New Drug Application
Approval Date: 14-NOV-01
Trade Name: LUPRON DEPOT
Dosage Form: SUSPENSION
Applicant: TAP PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX

Application #: 020089 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 14-NOV-01
Trade Name: ZOVIRAX
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Application #: 020089 Labeling Supplement #: 015
To Original New Drug Application
Approval Date: 14-NOV-01
Trade Name: ZOVIRAX
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Application #: 019909 Labeling Supplement #: 017
To Original New Drug Application
Approval Date: 14-NOV-01
Trade Name: ZOVIRAX
Dosage Form: SUSPENSION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Application #: 019909 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 14-NOV-01
Trade Name: ZOVIRAX
Dosage Form: SUSPENSION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Application #: 018828 Labeling Supplement #: 027
To Original New Drug Application
Approval Date: 14-NOV-01
Trade Name: ZOVIRAX
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Application #: 018828 Labeling Supplement #: 026
To Original New Drug Application
Approval Date: 14-NOV-01
Trade Name: ZOVIRAX
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Application #: 019766 Labeling Supplement #: 053
To Original New Drug Application
Approval Date: 14-NOV-01
Trade Name: ZOCOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): SIMVASTATIN
OTC/RX Status: RX

Application #: 019766 Labeling Supplement #: 045
To Original New Drug Application
Approval Date: 14-NOV-01
Trade Name: ZOCOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): SIMVASTATIN
OTC/RX Status: RX

Application #: 018684 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 14-NOV-01
Trade Name: BRANCHAMIN 4%
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): AMINO ACIDS
OTC/RX Status: RX

Application #: 050689 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 09-NOV-01
Trade Name: MYCOBUTIN
Dosage Form: CAPSULE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): RIFABUTIN
OTC/RX Status: RX

Application #: 050689 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 09-NOV-01
Trade Name: MYCOBUTIN
Dosage Form: CAPSULE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): RIFABUTIN
OTC/RX Status: RX

Application #: 018821 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 07-NOV-01
Trade Name: REGLAN
Dosage Form: SOLUTION
Applicant: AH ROBINS CO
Active Ingredient(s): METOCLOPRAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017862 Labeling Supplement#: 048
To Original New Drug Application
Approval Date: 07-NOV-01
Trade Name: REGLAN
Dosage Form: INJECTABLE
Applicant: AH ROBINS CO
Active Ingredient(s): METOCLOPRAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017854 Labeling Supplement#: 041
To Original New Drug Application
Approval Date: 07-NOV-01
Trade Name: REGLAN
Dosage Form: TABLET
Applicant: AH ROBINS CO
Active Ingredient(s): METOCLOPRAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 021246 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 05-NOV-01
Trade Name: TAMIFLU
Dosage Form: SUSPENSION
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): OSELTAMIVIR PHOSPHATE
OTC/RX Status: RX

Application #: 021087 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 05-NOV-01
Trade Name: TAMIFLU
Dosage Form: CAPSULE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): OSELTAMIVIR PHOSPHATE
OTC/RX Status: RX

Application #: 019059 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 01-NOV-01
Trade Name: INDERIDE LA 80/50
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): PROPRANOLOL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 018031 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 01-NOV-01
Trade Name: INDERIDE-40/25
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): PROPRANOLOL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX