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Details for New Drug Application (NDA): 090937

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NDA 090937 describes GLYBURIDE, which is a drug marketed by Aurobindo Pharma, Heritage Pharms Inc, Actavis Elizabeth, Zydus Pharms Usa Inc, Corepharma, Pharmadax Inc, Teva, Sanofi Aventis Us, Sandoz, Hikma, Dava Pharms Inc, Mylan, and Impax Labs Inc, and is included in twenty-one NDAs. It is available from thirty-seven suppliers. Additional details are available on the GLYBURIDE profile page.

The generic ingredient in GLYBURIDE is glyburide; metformin hydrochloride. There are twenty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.

Summary for NDA: 090937

Heritage Pharms Inc
Therapeutic Class:Blood Glucose Regulators

Pharmacology for NDA: 090937

Ingredient-typeSulfonylurea Compounds

Suppliers and Packaging for NDA: 090937

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 090937 ANDA Blenheim Pharmacal, Inc. 10544-232 10544-232-30 30 TABLET in 1 BOTTLE (10544-232-30)
TABLET;ORAL 090937 ANDA Blenheim Pharmacal, Inc. 10544-300 10544-300-90 90 TABLET in 1 BOTTLE (10544-300-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.25MG
Approval Date:Feb 28, 2011TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Feb 28, 2011TE:AB1RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 28, 2011TE:AB1RLD:No

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