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Details for New Drug Application (NDA): 078596

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NDA 078596 describes METFORMIN HYDROCHLORIDE, which is a drug marketed by Apotex, Ranbaxy Labs Ltd, Torrent Pharms, Mylan, Torrent Pharm, Sun Pharma Global, Aurobindo Pharma Ltd, Watson Labs Inc, Cspc Ouyi Pharm Co, Ipca Labs Ltd, Sandoz, Sun Pharm Inds, Torrent Pharms Ltd, Teva, Atlas Pharms Llc, Sun Pharm Inds (in), Ivax Sub Teva Pharms, Indicus Pharma, Impax Labs, Actavis Elizabeth, Provident Pharm, Actavis Labs Fl Inc, 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 sixty-eight NDAs. It is available from seventy-nine 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. Eighty-five suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the metformin hydrochloride profile page.

Summary for NDA: 078596

Amneal Pharms Ny
metformin hydrochloride
Therapeutic Class:Blood Glucose Regulators

Pharmacology for NDA: 078596


Suppliers and Packaging for NDA: 078596

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 078596 ANDA Blenheim Pharmacal, Inc. 10544-535 10544-535-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10544-535-30)
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 078596 ANDA Aidarex Pharmaceuticals LLC 33261-372 33261-372-02 120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (33261-372-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jan 3, 2008TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Jan 3, 2008TE:ABRLD:No

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