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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219159
Company: GRAVITI PHARMS

Products on ANDA 219159

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219159

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219159

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	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	219159	GRAVITI PHARMS
GLIPIZIDE	GLIPIZIDE	5MG	TABLET;ORAL	Prescription	No	AB	074378	OXFORD PHARMS
GLIPIZIDE	GLIPIZIDE	5MG	TABLET;ORAL	Prescription	No	AB	214874	RUBICON RESEARCH
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	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	219159	GRAVITI PHARMS
GLIPIZIDE	GLIPIZIDE	10MG	TABLET;ORAL	Prescription	No	AB	074378	OXFORD PHARMS
GLIPIZIDE	GLIPIZIDE	10MG	TABLET;ORAL	Prescription	No	AB	214874	RUBICON RESEARCH
GLIPIZIDE	GLIPIZIDE	10MG	TABLET;ORAL	Prescription	No	AB	074223	WATSON LABS TEVA

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