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Details for New Drug Application (NDA): 090666

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NDA 090666 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 eighty-two suppliers. Additional details are available on the METFORMIN HYDROCHLORIDE profile page.

The generic ingredient in METFORMIN HYDROCHLORIDE is metformin hydrochloride. There are forty-seven drug master file entries for this compound. Eighty-eight 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: 090666

Tradename:
METFORMIN HYDROCHLORIDE
Applicant:
Apotex
Ingredient:
metformin hydrochloride
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 090666

Ingredient-typeBiguanides

Suppliers and Packaging for NDA: 090666

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL 090666 ANDA Apotex Corp. 60505-0190 60505-0190-0 100 TABLET, FILM COATED in 1 BOTTLE (60505-0190-0)
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL 090666 ANDA Apotex Corp. 60505-0190 60505-0190-1 500 TABLET, FILM COATED in 1 BOTTLE (60505-0190-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Dec 7, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength850MG
Approval Date:Dec 7, 2011TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1GM
Approval Date:Dec 7, 2011TE:ABRLD:No


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