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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074686
Company: TEVA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYBURIDE (MICRONIZED) GLYBURIDE 1.5MG TABLET;ORAL Prescription AB No No
GLYBURIDE (MICRONIZED) GLYBURIDE 3MG TABLET;ORAL Prescription AB No No
GLYBURIDE (MICRONIZED) GLYBURIDE 4.5MG TABLET;ORAL Prescription None No No
GLYBURIDE (MICRONIZED) GLYBURIDE 6MG TABLET;ORAL Prescription AB 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
04/20/1999 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74686ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074686_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2019 SUPPL-28 Labeling-Package Insert

Label is not available on this site.
09/02/2015 SUPPL-27 Labeling-Package Insert

Label is not available on this site.
03/24/2014 SUPPL-25 Labeling-Package Insert

Label is not available on this site.
08/18/2011 SUPPL-20 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
04/28/2010 SUPPL-19 Labeling-Package Insert

Label is not available on this site.
05/06/2009 SUPPL-18 Labeling

Label is not available on this site.
05/06/2009 SUPPL-17 Labeling

Label is not available on this site.
10/02/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
10/02/2002 SUPPL-9 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.
10/02/2002 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.
07/01/2002 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.
09/13/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
02/15/2000 SUPPL-5 Labeling

Label is not available on this site.
08/28/2000 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/28/2000 SUPPL-3 Labeling

Label is not available on this site.

GLYBURIDE (MICRONIZED)

TABLET;ORAL; 1.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE (MICRONIZED) GLYBURIDE 1.5MG TABLET;ORAL Prescription No AB 074686 TEVA
GLYNASE GLYBURIDE 1.5MG TABLET;ORAL Prescription Yes AB 020051 PFIZER

TABLET;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE (MICRONIZED) GLYBURIDE 3MG TABLET;ORAL Prescription No AB 074686 TEVA
GLYNASE GLYBURIDE 3MG TABLET;ORAL Prescription Yes AB 020051 PFIZER

TABLET;ORAL; 6MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE (MICRONIZED) GLYBURIDE 6MG TABLET;ORAL Prescription No AB 074686 TEVA
GLYNASE GLYBURIDE 6MG TABLET;ORAL Prescription Yes AB 020051 PFIZER
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