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,...
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_FEB_1999.HTML Firm Date BRETHINE Terbutaline Sulfate Tablet 17-849 032 Novartis Pharms 2-Feb-1999 CHLOROMYCETIN Chloramphenicol Opth Ointment 50-156 038 Parkedale 3-Feb-1999 PRILOSEC Omeprazole Delayed-Release Capsule 19-810 057 Astra Merck 3-Feb-1999 TRANSDERM-NITRO Nitroglycerin Transdermal System 20-144 018 Novartis Pharms 3-Feb-1999 PRIMAXIN Cilastatin Sodium/Imipenem Injection 50-587 50-630...
Prescription and OTC Drug Product List 11/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 11: November 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE AMOXICILLIN - ADD - TABLET; ORAL TABLET; ORAL - ADD - TRIZIVIR AMOXICILLIN - ADD - + GLAXO WELLCOME EQ 300MG BASE;150MG;300MG N21205 001 - ADD -...
Prescription and OTC Drug Product List 1/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 1: January 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST PRESCRIPTION DRUG PRODUCT LIST 1 20TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / JAN'2000 - ADD - CALCIUM CHLORIDE CEFTIBUTEN DIHYDRATE -...
FDA Drug Approvals List- February 1999 Applicant: CONNETICS CORP Active Ingredient(s): BETAMETHASONE VALERATE OTC/RX Status: RX Indication(s):For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp Original Application #: 020969 Approval Date: 25-FEB-99 Trade Name: UVADEX Chemical Type: 3 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: THERAKOS INC...
FDA Drug Approvals List- June 1998 Drug Approvals for June 1998 Definitions and Notes June 1998 Original New Drug Applications Original Application #: 020865 Approval Date: 29-JUN-98 Trade Name: MAXALT - MLTRA ISC Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC Active Ingredient(s): RIZATRIPTAN BENZOATE OTC/RX Status: RX Indication(s): Acute...
DDPA December 1995 Drug and Device Approvals-December 1995 December 1995 - FDA Drug and Device Product Approvals ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-628 INVIRASE ROCHE SAQUINAVIR MESYLATE 06-DEC-95 (CAPSULE) NUTLEY, NJ EQ 200MG BASE (1 P, AA*, E**, H***) 07110 (ANTIVIRAL) [TREATMENT OF ADVANCED HIV INFECTION IN SELECTED PATIENTS IN COMBINATION WITH NUCLEOSIDE ANALOGUES] 19-835...
DDPA September 1995 50-685 CEDAX SCHERING PLOUGH CEFTIBUTEN DIHYDRATE 07-SEP-95 (CAPSULE) KENILWORTH, NJ EQ 400MG BASE 07033 (CEPHALOSPORIN) 50-686 CEDAX SCHERING PLOUGH CEFTIBUTEN DIHYDRATE 07-SEP-95 (POWDER, KENILWORTH, NJ EQ 90MG BASE/5ML FOR ORAL 07033 EQ 180MG BASE/5ML SUSPENSION) (CEPHALOSPORIN) 20-498 CASODEX ZENECA BICALUTAMIDE 14-SEP-95 (TABLET) WILMINGTON,...
Drug Approvals October 1996 Drug Approvals for October 1996 Definitions and Notes October 1996 Original New Drug Applications Original Application #: 019821 Approval Date: 28-OCT-96 Trade Name: SORIATANE Chemical Type: 2 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: HOFFMAN-LAROCHE Active Ingredient(s): ACITRETIN OTC/RX Status: RX Indication(s): Treatment of severe psoriasis Original Application #:...
Latest News Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information Biovail, Schering-Plough Terminate CEDAX Agreements; Shionogi & Co.CEDAX in United States TORONTO, Aug 27, 2004 (BUSINESS WIRE) -- Biovail Corporation (NYSE:BVF) ...
Cephalosporins for urinary tract infections (UTIs) - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About Cephalosporins for urinary tract infections (UTIs) - [Medication] - Quest Diagnostics Patient Health Library Cephalosporins for urinary tract infections (UTIs) - [Medication] - Quest Diagnostics Patient Health Library Urinary system, Antibiotic, Antibiotics, Bladder...
Cephalosporins for pneumonia - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Cephalosporins for pneumonia - [Medication] - Quest Diagnostics Patient Health Library Cephalosporins for pneumonia - [Medication] - Quest Diagnostics Patient Health Library Lungs and airways, Antibiotic, Antibiotics, Ceclor, Cedax, Cefaclor,...
2002 Warning Letters and Untitled Letters to Pharmaceutical Companies Food and Drug Administration • Center for Drug Evaluation and Research Compliance Activities Search Warning Letters and Untitled Letters to Pharmaceutical Companies 2002 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
author: STAUFFERP
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_JUN_1998.HTML Reference Listed Drug Labeling Approved in June 1998 Some of the product names below contain links to the approved labeling or the supplemental approval letter describing the specific changes.- Click on the product name to view the approved labeling changes in Adobe Acrobat format
Drug Approvals for May 1997 orbiculare) Application #:020297Efficacy Supplement#:001 Type: SE1 to Original New Drug Application Approval Date: 29-MAY-97 Trade Name: COREG Dosage Form: TABLET Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): CARVEDILOL OTC/RX Status: RX Efficacy Claim: For the new indication of congestive heart failure and a new dosage strength of 3.125 mg Application #...
