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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074497
Company: ANI PHARMS
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
08/31/1995 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
12/20/2019 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

12/20/2019 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

05/25/2011 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

01/27/2010 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

03/11/2009 SUPPL-18 Labeling

Label is not available on this site.

04/25/2008 SUPPL-15 Labeling

Label is not available on this site.

07/29/2002 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

04/29/2002 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/12/2001 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

05/31/2000 SUPPL-4 Labeling

Label is not available on this site.

05/31/2000 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

10/20/1998 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
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 075795 APOTEX
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 074226 AUROBINDO PHARMA USA
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

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
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 075795 APOTEX
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 074226 AUROBINDO PHARMA USA
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
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