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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 206531


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NDA 206531 describes FAMOTIDINE, which is a drug marketed by Ajanta Pharma Ltd, Akorn, Alkem Labs Ltd, Amneals Pharms, Annora Pharma, Carnegie, Cerovene Inc, Lupin Ltd, Micro Labs, Navinta Llc, Novel Labs Inc, Novitium Pharma, 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, Mylan, Mylan Pharms Inc, P And L, Perrigo R And D, Rising, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Vkt Pharma, Watson Labs, Epic Pharma Llc, Abbvie, and Baxter Hlthcare, and is included in eighty-one NDAs. It is available from one hundred and twenty-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-two suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.
Summary for 206531
Tradename:FAMOTIDINE
Applicant:Aurobindo Pharma
Ingredient:famotidine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206531
Medical Subject Heading (MeSH) Categories for 206531
Suppliers and Packaging for NDA: 206531
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMOTIDINE famotidine TABLET;ORAL 206531 ANDA WALGREEN CO. 0363-1899 0363-1899-14 1 BOTTLE in 1 CARTON (0363-1899-14) / 50 TABLET, FILM COATED in 1 BOTTLE
FAMOTIDINE famotidine TABLET;ORAL 206531 ANDA WALGREEN CO. 0363-1899 0363-1899-24 1 BOTTLE in 1 CARTON (0363-1899-24) / 90 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Apr 26, 2016TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength20MG
Approval Date:Apr 26, 2016TE:RLD:No

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