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Details for New Drug Application (NDA): 076467

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NDA 076467 describes GLIPIZIDE, which is a drug marketed by Sandoz, Barr Labs Inc, Sun Pharm Inds Inc, Watson Labs, Mylan, Accord Hlthcare, Par Pharm, Vintage Pharms Llc, Ani Pharms Inc, Apotex, Mylan Pharms Inc, Zydus Pharms Usa Inc, Corepharma, Heritage Pharms Inc, and Teva Pharms, and is included in twenty-two NDAs. It is available from forty-six suppliers. Additional details are available on the GLIPIZIDE profile page.

The generic ingredient in GLIPIZIDE is glipizide; metformin hydrochloride. There are eighteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the glipizide; metformin hydrochloride profile page.

Summary for NDA: 076467

Watson Labs
Therapeutic Class:Blood Glucose Regulators

Pharmacology for NDA: 076467

Ingredient-typeSulfonylurea Compounds

Suppliers and Packaging for NDA: 076467

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET, EXTENDED RELEASE;ORAL 076467 ANDA Actavis Elizabeth LLC 0228-2898 0228-2898-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-2898-03)
TABLET, EXTENDED RELEASE;ORAL 076467 ANDA Actavis Elizabeth LLC 0228-2899 0228-2899-96 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-2899-96)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Sep 8, 2003TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Nov 7, 2003TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG
Approval Date:Mar 27, 2006TE:ABRLD:No

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