Prescription and Over-the-Counter Drug Product List: 1/2004 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETYLCYSTEINE >A> INJECTABLE; INTRAVENOUS >A> ACETADOTE >A> + CUMBERLAND PHARMS 6GM /30ML(200MG/ML) N21539 001 JAN 23, 2004 JAN NEWA ALBUTEROL SULFATE TABLET, EXTENDED RELEASE; ORAL ALBUTEROL SULFATE >D> AB PLIVA EQ 4MG BASE N76130 002 SEP 26, 2002 JAN CRLD >A> + EQ 4MG BASE N76130 002 SEP 26, 2002 JAN CRLD >D> AB EQ...
NDA Approvals for Calendar Year 2004 FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -NDA Approvals for Calendar Year 2004 Updated through January 31, 2004 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE 21604 Children's Elixsure IB Ibuprofen Taro Pharms 5 S 07-Jan-04 21539 Acetadote Acetylcysteine Cumberland...
C:\Data\Acetadote\AP Letter Final 012304 .doc Acetylcysteine has the following structural formula: CH3 N SH O COOH H Acetadote is supplied as a sterile solution in vials containing 20% w/ v (200 mg/ mL) acetylcysteineACETADOTE , administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen...
author: Paul Levine
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Drug Approvals - A This newly approved or tentatively approved drug listing is an interim page intended to provide timely information on new drug products as a more comprehensive page is developed
What's new at CDER by Date - U.S
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