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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202425
Company: APOTEX

Products on ANDA 202425

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	EQ 25MG BASE	TABLET;ORAL	Prescription	AB	No	No
SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	EQ 50MG BASE	TABLET;ORAL	Prescription	AB	No	No
SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	EQ 100MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202425

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/20/2026	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 202425

SITAGLIPTIN PHOSPHATE

TABLET;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
JANUVIA	SITAGLIPTIN PHOSPHATE	EQ 25MG BASE	TABLET;ORAL	Prescription	Yes	AB	021995	MSD
SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	202425	APOTEX
SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	202387	SANDOZ
SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	202327	WATSON LABS INC

TABLET;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
JANUVIA	SITAGLIPTIN PHOSPHATE	EQ 50MG BASE	TABLET;ORAL	Prescription	Yes	AB	021995	MSD
SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	202425	APOTEX
SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	202387	SANDOZ
SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	202327	WATSON LABS INC

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
JANUVIA	SITAGLIPTIN PHOSPHATE	EQ 100MG BASE	TABLET;ORAL	Prescription	Yes	AB	021995	MSD
SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	202425	APOTEX
SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	202387	SANDOZ
SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	202327	WATSON LABS INC

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