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Generated: January 17, 2019

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Details for New Drug Application (NDA): 074316

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NDA 074316 describes CIMETIDINE, which is a drug marketed by Apotex, Chartwell Molecules, Contract Pharmacal, Cycle Pharms Ltd, Dava Pharms Inc, Ivax Sub Teva Pharms, L Perrigo Co, Mylan, Perrigo, Pliva, Sandoz Inc, Teva, Upsher Smith Labs, Watson Labs Inc, Watson Labs Teva, Yaopharma Co Ltd, Hospira, Luitpold, Teva Parenteral, Vintage Pharms Llc, Ani Pharms Inc, Apotex Inc, G And W Labs Inc, Hi Tech Pharma, Lannett Co Inc, Pharm Assoc, and Wockhardt Bio Ag, and is included in forty-nine NDAs. It is available from twenty-three 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. One supplier is listed for this compound. Additional details are available on the cimetidine hydrochloride profile page.
Summary for 074316
Applicant:Watson Labs Inc
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 074316

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength800MG
Approval Date:Feb 28, 1996TE:RLD:No

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