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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 077270


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NDA 077270 describes GLIPIZIDE AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Dash Pharms, Epic Pharma Llc, Heritage, Sun Pharm Inds Inc, Teva Pharms, and Zydus Pharms Usa Inc, and is included in six NDAs. It is available from nine suppliers. Additional details are available on the GLIPIZIDE AND METFORMIN HYDROCHLORIDE profile page.

The generic ingredient in GLIPIZIDE AND METFORMIN HYDROCHLORIDE is glipizide; metformin hydrochloride. There are eighteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the glipizide; metformin hydrochloride profile page.
Summary for 077270
Pharmacology for NDA: 077270
Suppliers and Packaging for NDA: 077270
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide; metformin hydrochloride TABLET;ORAL 077270 ANDA Teva Pharmaceuticals USA, Inc. 0093-7455 0093-7455-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-7455-01)
GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide; metformin hydrochloride TABLET;ORAL 077270 ANDA Teva Pharmaceuticals USA, Inc. 0093-7456 0093-7456-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-7456-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;250MG
Approval Date:Oct 28, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;500MG
Approval Date:Oct 28, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;500MG
Approval Date:Oct 28, 2005TE:ABRLD:No

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