Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074686

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NDA 074686 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 four 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. Thirty-two suppliers are listed for this compound. Additional details are available on the glyburide profile page.
Summary for 074686
Tradename:GLYBURIDE (MICRONIZED)
Applicant:Teva
Ingredient:glyburide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074686
Medical Subject Heading (MeSH) Categories for 074686
Suppliers and Packaging for NDA: 074686
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYBURIDE (MICRONIZED) glyburide TABLET;ORAL 074686 ANDA Teva Pharmaceuticals USA, Inc. 0093-8034 0093-8034-01 100 TABLET in 1 BOTTLE (0093-8034-01)
GLYBURIDE (MICRONIZED) glyburide TABLET;ORAL 074686 ANDA Teva Pharmaceuticals USA, Inc. 0093-8035 0093-8035-01 100 TABLET in 1 BOTTLE (0093-8035-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.5MG
Approval Date:Apr 20, 1999TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Apr 20, 1999TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4.5MG
Approval Date:Apr 20, 1999TE:ABRLD:No

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