Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074223
Company: WATSON LABS TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription AB No No
GLIPIZIDE GLIPIZIDE 10MG 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
02/27/1995 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
01/05/2016 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

07/26/2013 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

06/13/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/2002 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

09/25/2001 SUPPL-6 Labeling

Label is not available on this site.

09/05/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/20/2000 SUPPL-4 Labeling

Label is not available on this site.

11/05/1999 SUPPL-3 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

11/10/1999 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/13/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

GLIPIZIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 074550 ACCORD HLTHCARE
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 074497 ANI PHARMS INC
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 075795 APOTEX
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 074226 MYLAN
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 074305 SANDOZ
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 077820 SUN PHARM INDS INC
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 074223 WATSON LABS TEVA
GLUCOTROL GLIPIZIDE 5MG TABLET;ORAL Prescription Yes AB 017783 PFIZER

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 074550 ACCORD HLTHCARE
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 074497 ANI PHARMS INC
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 075795 APOTEX
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 074226 MYLAN
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 074305 SANDOZ
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 077820 SUN PHARM INDS INC
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 074223 WATSON LABS TEVA
GLUCOTROL GLIPIZIDE 10MG TABLET;ORAL Prescription Yes AB 017783 PFIZER

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