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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074792

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NDA 074792 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 074792

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 074792

Ingredient-typeSulfonylurea Compounds

Medical Subject Heading (MeSH) Categories for 074792

Suppliers and Packaging for NDA: 074792

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYBURIDE (MICRONIZED) glyburide TABLET;ORAL 074792 ANDA Mylan Pharmaceuticals Inc. 0378-1113 0378-1113-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-1113-01)
GLYBURIDE (MICRONIZED) glyburide TABLET;ORAL 074792 ANDA Mylan Pharmaceuticals Inc. 0378-1125 0378-1125-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-1125-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.5MG
Approval Date:Jun 26, 1998TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Jun 26, 1998TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength6MG
Approval Date:Aug 17, 1999TE:ABRLD:No


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