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Drug Approvals - A NDA 20-872 2/25/00 2/29/00 2/29/00 2/19/02 Allegra (Fexofenadine HCI) Tablets Aventis Pharmaceuticals NDA 20-872/S1, 2 & 4 10/29/01 11/8/01 - 11/8/01 Allegra (fexofenadine HCl) Capsules and Tablets,- Aventis Pharmaceuticals NDA 20-625/S12, 20-872/S11 & 20-786/S14 5/12/03 7/10/03 7/10/03 - Allegra (fexofenadine HCl) Capsules and Tablets,- Aventis Pharmaceuticals NDA 20-625/S-010...
What's new at CDER by Date Zometa (zoledronic acid) Injection, Novartis Pharmaceuticals Fexofenadine HCI & Pseudoephedrine HCI Extended-Release Tablets, Impax Laboratories, Tentative Approval News Along the Pike; January-February 2004 [ HTML ] or [ PDF ] Orange Book Query Warning Letters and Notice of Violation Letters to Pharmaceutical Companies February 26, 2004 Drug Shortages; Resolved: Amytal ...
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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...
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EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 *Supplement Type Description for SE1 - SE7 N (Chemical Type 6) SE1 SE2 SE3 SE4 SE5 SE6 SE7 NDA Type 6 - New Indication New or modified indication New dosage regimen New route of administration Comparative efficacy claim Patient population altered Change the marketing status from prescription to over the counter use Complete the traditional approval of a product originally approved...
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FDA Drug Approvals List July 2001 PERRIGO COMPANY Active Ingredient(s):ACETAMINOPHEN; ASPIRIN;CAFFEINE OTC/RX Status: RX Labeling Supplements to Original New Drug Applications Application #: 019906 Labeling Supplement#: 009 To Original New Drug Application Approval Date: 31-JUL-01 Trade Name: ANAFRANIL Dosage Form: CAPSULE Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE ...
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ranbaxy - - - - - - You are here :- Home - Products - - Dosage Forms - INDIA DOSAGE FORMS LIST- (Updated Jan 2002) Anti-infectives G.I. & Nutritionals CVS & Diabetes CNS NSAID & related Anti-allergants ...
ranbaxy - - - - - You are here :- Home - International Operations - - Global API- Products PRODUCTS Anti-Infectives Semi-synthetic Penicillins Amoxycillin Trihydrate Ampicillin Trihydrate Cloxacillin Sodium ...
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Prescription and OTC Drug Product List 2/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 2: February 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE CICLOPIROX TABLET; ORAL CREAM; TOPICAL LORTAB LOPROX - DLT - UCB 325MG;5MG N40099 001 - ADD - + AVENTIS PHARMS 0.77% N18748 001 - DLT - JUN 25, 1997 - ADD -...
FDA Drug Approvals List July 1999 Drug Approvals for July 1999 Definitions and Notes Original New Drug Applications Original Application #: 021057 Approval Date: 29-JUL-99 Trade Name: ANTAGON Chemical Type: 1 Therapeutic Potential: P Dosage Form: INJECTABLE Applicant: ORGANON INC Active Ingredient(s): GANIRELIX ACETATE OTC/RX Status: RX Indication(s): Provides for the inhibition of premature LH surges in women...
FDA Drug Approvals List- December 1998 Drug Approvals for December 1998 Definitions and Notes December 1998 Original New Drug Applications Original Application #: 020998 Approval Date: 31-DEC-98 Trade Name: CELEBREX Chemical Type: 1 Therapeutic Potential: P Dosage Form: CAPSULE Applicant: GD SEARLE AND CO Active Ingredient(s): CELECOXIB OTC/RX Status: RX Indication(s):For the signs and symptoms of osteoarthritis and...
