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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 075400


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NDA 075400 describes FAMOTIDINE, which is a drug marketed by Ajanta Pharma Ltd, Akorn, Alkem Labs Ltd, Amneals Pharms, Annora Pharma, Carnegie, Epic Pharma Llc, Lupin Ltd, Micro Labs, Navinta Llc, Novel Labs Inc, Novitium Pharma, Unichem, Upsher Smith Labs, Apotex Inc, Apothecon, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Sagent, Zydus Pharms, Perrigo, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Ascent Pharms Inc, Aurobindo Pharma, Aurobindo Pharma Ltd, Carlsbad, Chartwell Rx, Contract Pharmacal, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Graviti Pharms, Ivax Sub Teva Pharms, Mankind Pharma, Marksans Pharma, MSN, Mylan Pharms Inc, Natco Pharma, P And L, Perrigo R And D, Rising, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Vkt Pharma, Watson Labs, Torrent, Abbvie, Baxter Hlthcare, and Endo Operations, and is included in eighty-seven NDAs. It is available from one hundred and thirty-eight 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-three suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.
Summary for 075400
Tradename:FAMOTIDINE
Applicant:Perrigo
Ingredient:famotidine
Patents:0
Pharmacology for NDA: 075400
Medical Subject Heading (MeSH) Categories for 075400
Suppliers and Packaging for NDA: 075400
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMOTIDINE famotidine TABLET;ORAL 075400 ANDA L. Perrigo Company 0113-0141 0113-0141-65 30 BLISTER PACK in 1 CARTON (0113-0141-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK
FAMOTIDINE famotidine TABLET;ORAL 075400 ANDA Walgreen Company 0363-0141 0363-0141-65 30 BLISTER PACK in 1 CARTON (0363-0141-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Mar 18, 2005TE:RLD:No

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