Drug Approvals - A Agenerase- (amprenavir) Capsules and Oral Solution, Rx GlaxoSmithKline NDA 21-007/S6 NDA 21-039/S6 5/11/01 12/18/01 12/18/01 12/18/01 Aggrastat (tirofiban hydrochloride) Premixed Injection, 0.05 mg/mL, Rx Merck & Co., IncAggrastat (tirofiban hydrochloride) Injection & Premixed Injection,12.5 mg per 50 mL...
http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
Prescription and Over-the-Counter Drug Product List: 10/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 500MG/15ML;7.5MG/15ML N40520 001 OCT 30, 2003 OCT NEWA TABLET; ORAL ANEXSIA >D> AA MALLINCKRODT 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA >A> AA 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA ALBUTEROL SULFATE TABLET...
20912S001_Aggrastat.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Aggrastat (Tirofiban Hydrochloride) Injection & Premixed Injection Company:- Merck Research Laboratories Application No.:- 20912/S1 & 20913/S1 Approval Date:-7/9/1999 - Approval Letter(s) - Printed Labeling - Chemistry Review(s) - Administrative Document(s) - - Back...
author: Paul Stauffer
FDA Drug Approvals List September 2001 - Drug Approvals for September 2001 Definitions and Notes Original New Drug Applications Original Application #: 021279 Approval Date: 25-SEP-01 Trade Name: FORADIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: POWDER, FOR INHALATION Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): FORMOTEROL FUMARATE OTC/RX Status: RX Indication(s): For the long-term, twice...
FDA Drug Approvals List March 2001 Original Application #: 021082 Approval Date: 01-MAR-01 Trade Name: TAVIST ALLERGY/SINUS/HEADACHE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET Applicant: NOVARTIS CONSUMER HEALTH INC Active Ingredient(s): ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE OTC/RX Status: OTC Indication(s): For temporary relief of symptoms associated with hay fever...
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 June 2002 - Drug Approvals for June 2002 Definitions and Notes Original New Drug Applications Original Application # 021316 Approval Date: 26-JUN-02 Trade Name: ALTOCOR Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: AURA LABORATORIES INC Active Ingredient(s): LOVASTATIN OTC/RX Status: RX INDICATION OF USE: For lowering total cholesterol and LDL-C to target levels as...
http://www.merck.com/product/usa/pi_circulars/a/aggrastat/aggrastat_pi.pdf AGGRASTAT ® (Tirofiban Hydrochloride Injection Premixed) 9123311 AGGRASTAT ® (Tirofiban Hydrochloride Injection) 07- 19- 29- 498 6 CONTRAINDICATIONS AGGRASTAT is contraindicated in patients with: ° known hypersensitivity to any component of the product ° active internal bleeding or a history of bleeding diathesis within...
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http://www.fda.gov/cder/foi/label/2001/20913s6lbl.pdf 9123306 07- 19- 11- 970 1 AGGRASTAT ® (TIROFIBAN HYDROCHLORIDE INJECTION PREMIXED) AGGRASTAT ® (TIROFIBAN HYDROCHLORIDE INJECTION) DESCRIPTION AGGRASTAT * (tirofiban hydrochloride), a non- peptide antagonist of the platelet glycoprotein (GP) IIb/ IIIa receptor, inhibits platelet aggregation
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