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Generated: November 20, 2018

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Details for New Drug Application (NDA): 017532

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NDA 017532 describes DIABETA, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from four suppliers. Additional details are available on the DIABETA profile page.

The generic ingredient in DIABETA 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 017532
Tradename:DIABETA
Applicant:Sanofi Aventis Us
Ingredient:glyburide
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 017532
Suppliers and Packaging for NDA: 017532
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIABETA glyburide TABLET;ORAL 017532 NDA AUTHORIZED GENERIC TEVA Pharmaceuticals USA Inc 0093-9364 0093-9364-01 100 TABLET in 1 BOTTLE (0093-9364-01)
DIABETA glyburide TABLET;ORAL 017532 NDA AUTHORIZED GENERIC TEVA Pharmaceuticals USA Inc 0093-9364 0093-9364-05 500 TABLET in 1 BOTTLE (0093-9364-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.25MG
Approval Date:May 1, 1984TE:AB2RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:May 1, 1984TE:AB2RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 1, 1984TE:AB2RLD:Yes

Expired US Patents for NDA 017532

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us DIABETA glyburide TABLET;ORAL 017532-003 May 1, 1984 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us DIABETA glyburide TABLET;ORAL 017532-003 May 1, 1984 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us DIABETA glyburide TABLET;ORAL 017532-001 May 1, 1984 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
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McKinsey
QuintilesIMS
Accenture

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