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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Fish and Richardson

Generated: November 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078321

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NDA 078321 describes METFORMIN HYDROCHLORIDE, which is a drug marketed by Apotex, Intellipharmaceutics, Ranbaxy Labs Ltd, Torrent Pharms, Mylan, Torrent Pharms Ltd, Sun Pharma Global, Aurobindo Pharma Ltd, Watson Labs Inc, Cspc Ouyi Pharm Co, Ipca Labs Ltd, Sandoz, Sun Pharm Inds, Beximco Pharms Usa, Teva, Atlas Pharms Llc, Sun Pharm Inds (in), Ivax Sub Teva Pharms, Indicus Pharma, Impax Labs, Actavis Elizabeth, Provident Pharm, Actavis Labs Fl Inc, Macleods Pharms Ltd, Nostrum Pharms Llc, Zydus Pharms Usa, Watson Labs Florida, Barr, Lupin Ltd, Granules India, Sun Pharm Inds Inc, Mylan Pharms Inc, Sciegen Pharms Inc, Glenmark Generics, Chartwell Life Sci, Watson Labs, Amneal Pharms Ny, Alkem, Zydus Hlthcare, Dr Reddys Labs Inc, Marksans Pharma, Inventia Hlthcare, and Aurobindo, and is included in seventy-one NDAs. It is available from ninety-three suppliers. Additional details are available on the METFORMIN HYDROCHLORIDE profile page.

The generic ingredient in METFORMIN HYDROCHLORIDE is metformin hydrochloride. There are forty-eight drug master file entries for this compound. Ninety-nine suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

Summary for 078321

Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 078321


Medical Subject Heading (MeSH) Categories for 078321

Suppliers and Packaging for NDA: 078321

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 078321 ANDA TAGI Pharma, Inc. 51224-007 51224-007-50 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51224-007-50)
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 078321 ANDA TAGI Pharma, Inc. 51224-007 51224-007-60 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51224-007-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Apr 17, 2008TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Apr 17, 2008TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Queensland Health
Cantor Fitzgerald
Federal Trade Commission
US Army

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