Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020055
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYBURIDE (MICRONIZED) GLYBURIDE 1.5MG TABLET;ORAL Discontinued None No No
GLYBURIDE (MICRONIZED) GLYBURIDE 3MG TABLET;ORAL Discontinued None No No
GLYBURIDE (MICRONIZED) GLYBURIDE 6MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/17/1992 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/08/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/05/1999 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/1998 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/24/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/13/1997 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1995 SUPPL-2 Labeling

Label is not available on this site.

02/07/1995 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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