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Details for New Drug Application (NDA): 074591

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NDA 074591 describes GLYBURIDE (MICRONIZED), which is a drug marketed by Sanofi Aventis Us, Sandoz, Teva, Hikma, Dava Pharms Inc, and Mylan, and is included in six NDAs. It is available from nine suppliers. Additional details are available on the GLYBURIDE (MICRONIZED) profile page.

The generic ingredient in GLYBURIDE (MICRONIZED) is glyburide. There are twenty drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the glyburide profile page.

Summary for NDA: 074591

Tradename:
GLYBURIDE (MICRONIZED)
Applicant:
Dava Pharms Inc
Ingredient:
glyburide
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 074591

Ingredient-typeSulfonylurea Compounds

Suppliers and Packaging for NDA: 074591

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYBURIDE (MICRONIZED)
glyburide
TABLET;ORAL 074591 ANDA DAVA Pharmaceuticals, Inc. 67253-460 67253-460-10 100 TABLET in 1 BOTTLE (67253-460-10)
GLYBURIDE (MICRONIZED)
glyburide
TABLET;ORAL 074591 ANDA DAVA Pharmaceuticals, Inc. 67253-460 67253-460-11 1000 TABLET in 1 BOTTLE (67253-460-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.5MG
Approval Date:Dec 22, 1997TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Dec 22, 1997TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4.5MG
Approval Date:Dec 22, 1997TE:ABRLD:No


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