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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Fuji
Baxter
Covington
UBS
Express Scripts
US Department of Justice
Dow
US Army

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075890

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NDA 075890 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 six 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-five suppliers are listed for this compound. Additional details are available on the glyburide profile page.
Summary for 075890
Tradename:GLYBURIDE (MICRONIZED)
Applicant:Hikma
Ingredient:glyburide
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 075890
Ingredient-typeSulfonylurea Compounds
Medical Subject Heading (MeSH) Categories for 075890
Suppliers and Packaging for NDA: 075890
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYBURIDE (MICRONIZED) glyburide TABLET;ORAL 075890 ANDA West-Ward Pharmaceuticals Corp 0143-9918 N 0143-9918-01
GLYBURIDE (MICRONIZED) glyburide TABLET;ORAL 075890 ANDA West-Ward Pharmaceuticals Corp 0143-9918 N 0143-9918-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.5MG
Approval Date:Jul 31, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Jul 31, 2003TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength6MG
Approval Date:Jul 31, 2003TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Colorcon
McKinsey
Citi
Moodys
Queensland Health
McKesson
Cantor Fitzgerald
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