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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076467
Company: WATSON LABS

Products on ANDA 076467

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076467

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
12/17/2019	SUPPL-26	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
12/17/2019	SUPPL-25	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
12/17/2019	SUPPL-24	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 076467

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
GLIPIZIDE	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204720	UNIQUE
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
GLIPIZIDE	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204720	UNIQUE
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
GLIPIZIDE	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204720	UNIQUE
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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