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/orange/appendix_a.txt APPENDIX A PRODUCT NAME INDEX ** 0 ** 0, AMOXICILLIN ** 8 ** 8-HOUR BAYER, ASPIRIN (OTC) 8-MOP, METHOXSALEN ** A ** A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE A-N STANNOUS AGGREGATED ALBUMIN, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT A-POXIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE A.P.L., GONADOTROPIN, CHORIONIC A/T/S, ERYTHROMYCIN...
FDA Drug Approvals List November 1999 Approvable Original New Drug Applications Original Application #: 020125 Approvable Date: 30-NOV-99 Trade Name: ACCURETIC Dosage Form: TABLET Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO Active Ingredient(s): QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE OTC/RX Status: RX Original Abbreviated Application #: 075366 Tentative Approval Date...
Drug Approvals - A Accupril and Accuretic (quinapril hydrochloride & hydrochlorothiazide) Tablets,- Pfizer Incquinapril hydrochloride) Tablets,- Pfizer Incquinapril hydrochloride) TabletsAccuretic Tablets, Rx ...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt LOUIS, MISSOURI" 12443 28-Mar-97 SCHERING PLOUGH PRODUCTS INC "STERILE WATER FOR INJECTION, MANUFACTURED IN MANATI, PUERTO RICO" 12444 26-Mar-97 ORION CORP FERMION "ENTACAPONE, MANUFACTURED IN HANKO AND ESPOO, FINLAND" 12445 18-Mar-97 NAPP TECHNOLOGIES INC "NABUMETONE, MANUFACTURED IN COVENTRY, RHODE ISLAND" 12449 03-Apr-97 PHARM ECO LABORATORIES INC "2-AMINO-5-PHENYL-4(5H)-OXAZOLONE...
FDA Drug Approvals List June 2001 PERRIGO COMPANY Active Ingredient(s): MONOXIDIL OTC/RX Status: RX Original Abbreviated Application # 075750 Approval Date: 8-JUN-01 Trade Name: DOXAZOSIN MESYLATE Dosage Form: TABLET Applicant: SIDMAK LABORATORIES, INC Active Ingredient(s): DOXAZOSIN MESYLATE OTC/RX Status: RX Original Abbreviated Application # 075502 Approval Date: 05-JUN-01 Trade Name: CLOTRIMAZOLE AND...
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 July 2002 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 #:...
FDA Drug Approvals List- February 1998 Drug Approvals for February 1998 Definitions and Notes February 1998 Original New Drug Applications Original Application #: 050750 Approval Date: 24-FEB-98 Trade Name: ZOSYN Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: LEDERLE PIPERACILLIN INC DIV AMERICAN CYANAMID CO Active Ingredient(s): PIPERACILLIN SODIUM; TAZOBACTAM SODIUM OTC/RX Status: RX...
FDA DRUG AND DEVICE PRODUCT APPROVALS 74-776 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE 26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.5% 33637 (BETA ADRENERGIC BLOCKER) 74-778 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE 26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.25% 33637 (BETA ADRENERGIC BLOCKER) 74-465 TIMOLOL MALEATE ADV REMEDIES TIMOLOL MALEATE 30-JUL-96 (SOLUTION/DROPS) SOMERSET, NJ 0.25% 08873 (BETA ADRENERGIC...
DDPA April 1996 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-262 TAXOL BRISTOL MYERS SQUIBB PACLITAXEL 01-APR-96 (INJECTABLE) WALLINGFORD, CT 6MG/ML 06492 (LABELING REVISION -- BOXED WARNING; DESCRIPTION; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION; HOW SUPPLIED) 18-602 CARDIZEM HOECHST MARION RSSL DILTIAZEM HYDROCHLORIDE 02-APR-96 (TABLET) KANSAS CITY, MO 30MG 64134...
July Drug Approvals Drug Approvals for July 1996 Definitions and Notes Original New Drug Application Original Application #: 020538 Approval Date: 31-JUL-96 Trade Name: ESTRADIOL Chemical Type: Already marketed drug product but a new manufacturer Therapeutic Potential: Standard review drug Dosage Form: FILM, EXTENDED RELEASE Applicant: MENOREST MANFACTURING INC Active Ingredient(s): ESTRADIOL OTC/RX...
20125_Accuretic.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Accuretic (quinapril HCI/hydrochlorothiazide) Tablets Company:- Parke-Davis Pharmaceuticals, Ltd
author: Paul Stauffer
