An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	Yes

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-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/23/2019	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert		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

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

Top