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Generated: December 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077351

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NDA 077351 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, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, Perrigo R And D, Pld Acquisitions, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Watson Labs, Wockhardt, Wockhardt Ltd, Abbvie, and Baxter Hlthcare, and is included in sixty-one NDAs. It is available from one hundred and ten 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 seventy-eight 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 077351
Tradename:FAMOTIDINE
Applicant:Perrigo R And D
Ingredient:famotidine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 077351
Suppliers and Packaging for NDA: 077351
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMOTIDINE famotidine TABLET;ORAL 077351 ANDA L. Perrigo Company 0113-0194 0113-0194-02 25 BLISTER PACK in 1 CARTON (0113-0194-02) > 1 TABLET in 1 BLISTER PACK
FAMOTIDINE famotidine TABLET;ORAL 077351 ANDA L. Perrigo Company 0113-7194 0113-7194-82 1 BOTTLE in 1 CARTON (0113-7194-82) > 200 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength20MG
Approval Date:Sep 25, 2006TE:RLD:No

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