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Last Updated: September 25, 2020

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Details for New Drug Application (NDA): 075302

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NDA 075302 describes FAMOTIDINE, which is a drug marketed by Hi-tech Pharma Co, Lupin Ltd, Navinta Llc, Novel Labs Inc, Apotex Inc, Apothecon, Athenex Inc, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, West-ward Pharms Int, Perrigo, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo Pharma Ltd, Carlsbad, Celltrion, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, P And L, Perrigo R And D, Pld Acquisitions, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Watson Labs, Wockhardt, Abbvie, and Baxter Hlthcare, and is included in sixty NDAs. It is available from eighty-seven 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 eighty-two drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.
Summary for 075302
Tradename:FAMOTIDINE
Applicant:Pld Acquisitions
Ingredient:famotidine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 075302

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
Approval Date:Apr 16, 2001TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength40MG
Approval Date:Apr 16, 2001TE:RLD:No

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