Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074226
Company: MYLAN
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
05/10/1994 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
04/11/2017 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

04/11/2017 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

07/26/2013 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

05/19/2009 SUPPL-10 Labeling

Label is not available on this site.

09/25/2001 SUPPL-3 Labeling

Label is not available on this site.

03/24/2000 SUPPL-2 Labeling

Label is not available on this site.

02/05/1998 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 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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