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Generated: September 24, 2018

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Details for New Drug Application (NDA): 077711

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Summary for 077711
Tradename:METFORMIN HYDROCHLORIDE
Applicant:Torrent Pharms
Ingredient:metformin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077711
Ingredient-typeBiguanides
Medical Subject Heading (MeSH) Categories for 077711
Suppliers and Packaging for NDA: 077711
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 077711 ANDA Torrent Pharmaceuticals Limited 13668-001 13668-001-01 100 TABLET, FILM COATED in 1 BOTTLE (13668-001-01)
METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 077711 ANDA Torrent Pharmaceuticals Limited 13668-001 13668-001-05 500 TABLET, FILM COATED in 1 BOTTLE (13668-001-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jan 24, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength850MG
Approval Date:Jan 24, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1GM
Approval Date:Jan 24, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
McKinsey
Cipla
Fish and Richardson
Daiichi Sankyo
Farmers Insurance
Baxter
Teva
Federal Trade Commission

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