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Serving leading biopharmaceutical companies globally:

Baxter
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Generated: December 16, 2017

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, 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-five suppliers are listed for this compound. Additional details are available on the glyburide profile page.

Summary for 074686

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

Pharmacology for NDA: 074686

Ingredient-typeSulfonylurea Compounds

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)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Fish and Richardson
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Covington
Dow
QuintilesIMS
Chinese Patent Office

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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