Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 15, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206531

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NDA 206531 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-one NDAs. It is available from one hundred and two 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-seven 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 Ltd
Ingredient:famotidine
Patents:0
Formulation / Manufacturing:see details
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 Wal-Mart Stores, Inc. 49035-505 49035-505-35 1 BOTTLE in 1 CARTON (49035-505-35) > 25 TABLET, FILM COATED in 1 BOTTLE
FAMOTIDINE famotidine TABLET;ORAL 206531 ANDA Magno-Humphries, Inc. 54257-180 54257-180-07 90 TABLET, FILM COATED in 1 BOTTLE (54257-180-07)

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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