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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075795
Company: APOTEX

Products on ANDA 075795

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075795

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75795ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2017	SUPPL-13	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
04/26/2016	SUPPL-12	Labeling-Patient Package Insert		Label is not available on this site.
07/26/2013	SUPPL-11	Labeling-Container/Carton Labels		Label is not available on this site.
07/26/2013	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
03/25/2009	SUPPL-8	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075795

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	214874	RUBICON
GLIPIZIDE	GLIPIZIDE	5MG	TABLET;ORAL	Prescription	No	AB	074305	SANDOZ
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	214874	RUBICON
GLIPIZIDE	GLIPIZIDE	10MG	TABLET;ORAL	Prescription	No	AB	074305	SANDOZ
GLIPIZIDE	GLIPIZIDE	10MG	TABLET;ORAL	Prescription	No	AB	074223	WATSON LABS TEVA

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