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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078641

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NDA 078641 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 thirteen 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-five 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 078641
Tradename:FAMOTIDINE
Applicant:Mylan Labs Ltd
Ingredient:famotidine
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078641
Medical Subject Heading (MeSH) Categories for 078641
Suppliers and Packaging for NDA: 078641
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMOTIDINE famotidine INJECTABLE;INJECTION 078641 ANDA Mylan Institutional LLC 67457-448 N 67457-448-43
FAMOTIDINE famotidine INJECTABLE;INJECTION 078641 ANDA Mylan Institutional LLC 67457-457 N 67457-457-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Jun 25, 2008TE:APRLD:No

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