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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204720
Company: UNIQUE

Products on ANDA 204720

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLIPIZIDE	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
GLIPIZIDE	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
GLIPIZIDE	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204720

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/2016	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
07/01/2022	SUPPL-11	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
04/23/2019	SUPPL-4	Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 204720

GLIPIZIDE

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

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

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