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Serving leading biopharmaceutical companies globally:

Express Scripts
Fish and Richardson
Boehringer Ingelheim

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074591

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NDA 074591 describes GLYBURIDE (MICRONIZED), which is a drug marketed by Dava Pharms Inc, Hikma, Mylan, Sandoz, Sanofi Aventis Us, and Teva, 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 074591

Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 074591

Ingredient-typeSulfonylurea Compounds

Medical Subject Heading (MeSH) Categories for 074591

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 Par Pharmaceutical 67253-460 67253-460-11 1000 TABLET in 1 BOTTLE (67253-460-11)
GLYBURIDE (MICRONIZED) glyburide TABLET;ORAL 074591 ANDA Par Pharmaceutical 67253-460 67253-460-50 500 TABLET in 1 BOTTLE (67253-460-50)

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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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Harvard Business School
Argus Health
US Department of Justice

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