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BioPharmaceutical Business Intelligence

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Serving 500+ biopharmaceutical companies globally:

Novartis
Covington
Baxter
Boehringer Ingelheim
Deloitte
McKesson
Argus Health
Farmers Insurance
Cerilliant
Daiichi Sankyo

Generated: September 23, 2017

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 Sanofi Aventis Us, Sandoz, Teva, Hikma, Dava Pharms Inc, and Mylan, 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-three suppliers are listed for this compound. Additional details are available on the glyburide profile page.

Summary for NDA: 075890

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

Pharmacology for NDA: 075890

Ingredient-typeSulfonylurea Compounds

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 0143-9918-01 100 TABLET in 1 BOTTLE, PLASTIC (0143-9918-01)
GLYBURIDE (MICRONIZED)
glyburide
TABLET;ORAL 075890 ANDA West-Ward Pharmaceuticals Corp 0143-9918 0143-9918-05 500 TABLET in 1 BOTTLE, PLASTIC (0143-9918-05)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving 500+ biopharmaceutical companies globally:

Colorcon
Mallinckrodt
AstraZeneca
Accenture
Express Scripts
Citi
Deloitte
Julphar
Baxter
Harvard Business School

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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