http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA...
Prescription and OTC Drug Product List 6/2002 -D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
FDA Drug Approvals List April 2000 Approvable Original New Drug Applications Original Abbreviated New Drug Applications Original Abbreviated Application # 074657 Approval Date: 28-APR-00 Trade Name: TERAZOSIN HCL Dosage Form: TABLET Applicant: INVAMED INC Active Ingredient(s): TERAZOSIN HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application# 065041 Approval Date: 28-APR-00 Trade Name:...
Drug Approvals for April 1997 Drug Approvals for April 1997 Definitions and Notes April 1997 Original New Drug Applications Original Application #: 020619 Approval Date: 17-APR-97 Trade Name: BETOPTIC PILO Chemical Type: 4 Therapeutic Potential: S Dosage Form: SUSPENSION/DROPS Applicant: ALCON LABORATORIES INC Active Ingredient(s): BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE OTC/RX Status: RX...
FDA Drug Approvals List- January 1998 Dosage Form: INJECTABLE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): GONADOTROPIN, CHORIONIC OTC/RX Status: RX Application #: 020729 Labeling Supplement#: 002 To Original New Drug Application Approval Date: 21-JAN-98 Trade Name: UNIRETIC Dosage Form: TABLET Applicant: SCHWARZ PHARMA INC Active Ingredient(s): HYDROCHLOROTHIAZIDE; MOEXIPRIL ...
Drug Approvals for June 1997 Drug Approvals for June 1997 Definitions and Notes June 1997 Original New Drug Applications Original Application #: 020729 Approval Date: 27-JUN-97 Trade Name: UNIRETIC Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET Applicant: SCHWARZ PHARMA INC Active Ingredient(s): HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE OTC/RX Status: RX Indication(s):...
1996 and Older - New Drug Application (NDA) 20195/S-002 5/20/96 8/2/99 Fragmin/dalteparin sodium Injection [1.5 MB] Pharmacia and Upjohn 020287/S005 9/24/1996 2/4/1998 Heptolite, Kit for the Preparation of Technetium Tc 99m Disofenin Merck 18467/ S-13 & S-14 12/29/1993 8/5/2003 Humulin R Lilly 018870/S37 1/11/1994 6/17/2003 Hydrocortisone and Acetic Acid - Morton Grove Pharmaceuticals 040168 08/30/1996 8/1/2003 Hyzaar ...
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt HERAEUS GMBH AND CO KG "CARBOPLATIN USP AS MFG IN HANAU, GERMANY" 15148 16-Nov-00 SOLMAG S.P.A METFORMIN HYDROCHLORIDE AS MFG IN MULAZZANO(LO)ITALY 15149 20-Nov-00 BAYER AG ASPIRIN USP AS MFG IN LA FELGUERA(ASTURIAS)SPAIN 15150 20-Nov-00 DESERET LABORATORIES INC "90:10 CALCIUM CARBONATE/STARCH GRANULATION AS MFG IN ST.GEORGE, UTAH" 15151 21-Nov-00 EMISPHERE TECHNOLOGIES INC "5...
FDA Drug Approvals List April 2001 - Drug Approvals for April 2001 Definitions and Notes Original New Drug Applications Original Application #: 020949 Approval Date: 30-APR-01 Trade Name: ACCUNEB Chemical Type: 5 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: DEY LABORATORIES INC Active Ingredient(s): ALBUTEROL SULFATE OTC/RX Status: RX Indication(s): For the treatment of asthma-related bronchospasm in...
FDA Drug Approvals List- April 1998 Application #: 020555 Efficacy Supplement#: 003 Type: SE1 to Original New Drug Application Approval Date: 01-APR-98 Trade Name: AXID AR Dosage Form: TABLET Applicant: WHITEHALL ROBINS HEALTHCARE Active Ingredient(s): NIZATIDINE OTC/RX Status: OTC Efficacy Claim: Provides for treatment of episodic heartburn, acid indigestion and sour stomach Application #: 020393 Efficacy Supplement#:...
DDPA April 1995 Drug and Device Approvals-April 1995 **ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-145 NITRO-DUR KEY PHARMS NITROGLYCERIN 04-APR-95 (FILM, KENILWORTH, NJ 0.1MG/HR (SUPPL-004)EXTENDED RELEASE) 07033 0.2MG/HR 0.3MG/HR 0.4MG/HR 0.6MG/HR 0.8MG/HR (VASODILATOR) [PREVENTION OF ANGINA PECTORIS] 19-829 CERETEC AMERSHAM TECHNETIUM TC-99M 07-APR-95 (INJECTABLE) ARLINGTON HEIGHTS...
Reference Listed Drug Labeling Approved in April 2000 Tradename Active Ingredient(s) / Dosage Form NDA/Sup# Firm April AMICAR Aminocaproic acid INJ 15-229 030 Immunex 3 AMICAR Aminocaproic acid TAB 15-197 034 Immunex 3 LO/OVRAL Norgestrel/ethinyl estradiol TAB 17-612 031 Wyeth Ayerst 3 NORDETTE-21 Levonorgestrel/ethinyl estradiol TAB 18-668 030 Wyeth Ayerst 3 PREVEN Levonorgestrel/ ethinyl estradiol TAB 20-946 005 Gynetics 3 CALCIJEX...
author: GraceJ
C:\Data\My Documents\2002 NDA Letters\20729s010ap.doc page 1
author: Sandra Birdsong
