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Generated: November 17, 2018

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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, Sanofi Aventis Us, Teva, and Yaopharma Co Ltd, and is included in six NDAs. It is available from eight 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-one suppliers are listed for this compound. Additional details are available on the glyburide profile page.
Summary for 074792
Tradename:GLYBURIDE (MICRONIZED)
Applicant:Mylan
Ingredient:glyburide
Patents:0
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)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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