Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205994
Company: GLENMARK PHARMS LTD

Products on ANDA 205994

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SAXAGLIPTIN	SAXAGLIPTIN HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	AB	No	No
SAXAGLIPTIN	SAXAGLIPTIN HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205994

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/15/2023	ORIG-2	Tentative Approval		UNKNOWN		Label is not available on this site.
07/31/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 205994

SAXAGLIPTIN

TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SAXAGLIPTIN	SAXAGLIPTIN HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	205972	AUROBINDO PHARMA
SAXAGLIPTIN	SAXAGLIPTIN HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	205994	GLENMARK PHARMS LTD
SAXAGLIPTIN	SAXAGLIPTIN HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	205980	MYLAN

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SAXAGLIPTIN	SAXAGLIPTIN HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	205972	AUROBINDO PHARMA
SAXAGLIPTIN	SAXAGLIPTIN HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	205994	GLENMARK PHARMS LTD
SAXAGLIPTIN	SAXAGLIPTIN HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	205980	MYLAN