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Details for New Drug Application (NDA): 075758

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NDA 075758 describes FAMOTIDINE, which is a drug marketed by Perrigo, Sandoz, Mylan, Watson Labs, Hospira, Carlsbad, Apothecon, Fresenius Kabi Usa, Apotex, Ivax Sub Teva Pharms, Teva, Alembic Pharms Ltd, Dr Reddys Labs Ltd, Navinta Llc, Aurobindo Pharma Ltd, Wockhardt, Sun Pharm Inds, Lupin Ltd, Mylan Labs Ltd, Apotex Inc, Actavis Elizabeth, Amphastar Pharms Inc, Mylan Pharms Inc, Sun Pharm Inds Ltd, Eurohlth Intl Sarl, Hi-tech Pharma Co, Novel Labs Inc, Abbvie, Baxter Hlthcare, and Perrigo R And D, and is included in sixty-one NDAs. It is available from one hundred and thirteen suppliers. Additional details are available on the FAMOTIDINE profile page.

The generic ingredient in FAMOTIDINE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and fifty-three drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for NDA: 075758

Dr Reddys Labs Ltd
Therapeutic Class:Gastrointestinal Agents

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Aug 17, 2001TE:RLD:No

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