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Details for New Drug Application (NDA): 075607

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NDA 075607 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 fourteen 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-four 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: 075607

Tradename:
FAMOTIDINE
Applicant:
Sandoz
Ingredient:
famotidine
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
Approval Date:May 10, 2001TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength40MG
Approval Date:May 10, 2001TE:RLD:No


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