U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076257
Company: EPIC PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYBURIDE GLYBURIDE 1.25MG TABLET;ORAL Prescription AB1 No No
GLYBURIDE GLYBURIDE 2.5MG TABLET;ORAL Prescription AB1 No No
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription AB1 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
06/27/2002 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/13/2015 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

04/13/2015 SUPPL-10 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

09/30/2010 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

06/23/2010 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

08/19/2010 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/18/2009 SUPPL-4 Labeling

Label is not available on this site.

GLYBURIDE

TABLET;ORAL; 1.25MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE GLYBURIDE 1.25MG TABLET;ORAL Prescription No AB1 203379 CADILA PHARMS LTD
GLYBURIDE GLYBURIDE 1.25MG TABLET;ORAL Prescription No AB1 076257 EPIC PHARMA LLC
GLYBURIDE GLYBURIDE 1.25MG TABLET;ORAL Prescription No AB1 090937 HERITAGE
GLYBURIDE GLYBURIDE 1.25MG TABLET;ORAL Prescription No AB1 206483 ORIENT PHARMA CO LTD
GLYBURIDE GLYBURIDE 1.25MG TABLET;ORAL Prescription No AB1 074388 TEVA
GLYBURIDE GLYBURIDE 1.25mg TABLET;ORAL Prescription No AB1 206749 ZYDUS PHARMS

TABLET;ORAL; 2.5MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE GLYBURIDE 2.5MG TABLET;ORAL Prescription No AB1 203379 CADILA PHARMS LTD
GLYBURIDE GLYBURIDE 2.5MG TABLET;ORAL Prescription No AB1 076257 EPIC PHARMA LLC
GLYBURIDE GLYBURIDE 2.5MG TABLET;ORAL Prescription No AB1 090937 HERITAGE
GLYBURIDE GLYBURIDE 2.5MG TABLET;ORAL Prescription No AB1 206483 ORIENT PHARMA CO LTD
GLYBURIDE GLYBURIDE 2.5MG TABLET;ORAL Prescription No AB1 074388 TEVA
GLYBURIDE GLYBURIDE 2.5mg TABLET;ORAL Prescription No AB1 206749 ZYDUS PHARMS

TABLET;ORAL; 5MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription No AB1 203379 CADILA PHARMS LTD
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription No AB1 076257 EPIC PHARMA LLC
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription No AB1 090937 HERITAGE
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription No AB1 206483 ORIENT PHARMA CO LTD
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription No AB1 074388 TEVA
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription No AB1 206749 ZYDUS PHARMS
Back to Top