Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076467
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLIPIZIDE GLIPIZIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
GLIPIZIDE GLIPIZIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
GLIPIZIDE GLIPIZIDE 2.5MG TABLET, EXTENDED RELEASE;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
09/08/2003 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
09/10/2015 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

07/31/2013 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

02/18/2009 SUPPL-15 Labeling

Label is not available on this site.

03/26/2007 SUPPL-11 Labeling

Label is not available on this site.

03/27/2006 SUPPL-6 Labeling

Label is not available on this site.

03/27/2006 SUPPL-5 Manufacturing (CMC)-New Strength

Label is not available on this site.

11/07/2003 SUPPL-1

Label is not available on this site.

GLIPIZIDE

TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL Prescription No AB 206928 AUROBINDO PHARMA LTD
GLIPIZIDE GLIPIZIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076159 PAR PHARM
GLIPIZIDE GLIPIZIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204720 UNIQUE PHARM LABS
GLIPIZIDE GLIPIZIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076467 WATSON LABS
GLIPIZIDE GLIPIZIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203499 ZYDUS PHARMS
GLUCOTROL XL GLIPIZIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020329 PFIZER

TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL Prescription No AB 206928 AUROBINDO PHARMA LTD
GLIPIZIDE GLIPIZIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076159 PAR PHARM
GLIPIZIDE GLIPIZIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204720 UNIQUE PHARM LABS
GLIPIZIDE GLIPIZIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076467 WATSON LABS
GLIPIZIDE GLIPIZIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203499 ZYDUS PHARMS
GLUCOTROL XL GLIPIZIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020329 PFIZER

TABLET, EXTENDED RELEASE;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLIPIZIDE GLIPIZIDE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206928 AUROBINDO PHARMA LTD
GLIPIZIDE GLIPIZIDE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204720 UNIQUE PHARM LABS
GLIPIZIDE GLIPIZIDE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076467 WATSON LABS
GLIPIZIDE GLIPIZIDE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203499 ZYDUS PHARMS
GLUCOTROL XL GLIPIZIDE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020329 PFIZER

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