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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202327
Company: WATSON LABS INC

Products on ANDA 202327

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 202327

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/2025	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/202327Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 202327

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	MERCK SHARP DOHME
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	MERCK SHARP DOHME
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	MERCK SHARP DOHME
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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