http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
Prescription and Over-the-Counter Drug Product List: 5/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
News and Accomplishments December 17, 1999 - FDA Clearance for the Ez-HBT MSI receives final FDA clearance to market the Ez-HBT product and the 13 C -urea drug component Helicosol. - The Ez-HBT will be the first blood test to detect active bacterial infection of Helicobacter pylori, the cause of peptic ulcers
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 -...
FDA Drug Approvals List December 1999 Original Application #: 020845 Approval Date: 23-DEC-99 Trade Name: INOMAX Chemical Type: 1 Therapeutic Potential: P Dosage Form: INHALATION Applicant: INO THERAPEUTICS INC Active Ingredient(s): NITRIC OXIDE OTC/RX Status: RX Indication(s): For the treatment of term and near-term (-34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic...
http://www.fda.gov/cder/foi/label/1999/21092lbl.pdf Description of Helicosol ™ Diagnostic Drug Component The Helicosol ™ diagnostic drug component of the kit is 13 C - urea, a synthetic urea prepared as a lyophilized, white powder for reconstitution with sterile water (also provided in the kit) to produce a clear, colorless solution for oral administration
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21092_Helicosol.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Helicosol (C -urea) Lyophilized Powder Company:--Metabolic Solutions, Inc
author: Paul Stauffer
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