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Last Updated: September 25, 2020

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Details for New Drug Application (NDA): 090440

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NDA 090440 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 NDAs. It is available from eighty-seven 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-six suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.
Summary for 090440
Tradename:FAMOTIDINE
Applicant:Lupin Ltd
Ingredient:famotidine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090440
Medical Subject Heading (MeSH) Categories for 090440
Suppliers and Packaging for NDA: 090440
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMOTIDINE famotidine FOR SUSPENSION;ORAL 090440 ANDA Lupin Pharmaceuticals, Inc. 68180-150 68180-150-01 50 mL in 1 BOTTLE (68180-150-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength40MG/5ML
Approval Date:Jun 29, 2010TE:ABRLD:No

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