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Details for New Drug Application (NDA): 074963

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NDA 074963 describes CIMETIDINE, which is a drug marketed by Sandoz, Ivax Sub Teva Pharms, Upsher-smith Labs, Watson Labs Inc, Lek Pharms, Watson Labs, Vintage Pharms Llc, Dava Pharms Inc, Mylan, Apotex, Teva, Contract Pharmacal, Cycle Pharms Ltd, Pliva, Perrigo, Ani Pharms Inc, Hospira, Teva Parenteral, Luitpold, Pharm Assoc, Wockhardt, Apotex Inc, Hi Tech Pharma, and G And W Labs Inc, and is included in fifty NDAs. It is available from thirty-four suppliers. Additional details are available on the CIMETIDINE profile page.

The generic ingredient in CIMETIDINE is cimetidine hydrochloride. There are twenty-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cimetidine hydrochloride profile page.

Summary for NDA: 074963

Tradename:
CIMETIDINE
Applicant:
Contract Pharmacal
Ingredient:
cimetidine
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength200MG
Approval Date:Jun 19, 1998TE:RLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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