Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202388
Company: SANDOZ

Products on ANDA 202388

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	500MG;EQ 50MG BASE	TABLET;ORAL	Prescription	AB	No	No
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	1GM;EQ 50MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202388

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/02/2025	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/202388Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 202388

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

TABLET;ORAL; 500MG;EQ 50MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
JANUMET	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	500MG;EQ 50MG BASE	TABLET;ORAL	Prescription	Yes	AB	022044	MSD SUB MERCK
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	500MG;EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	202388	SANDOZ

TABLET;ORAL; 1GM;EQ 50MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
JANUMET	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	1GM;EQ 50MG BASE	TABLET;ORAL	Prescription	Yes	AB	022044	MSD SUB MERCK
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	1GM;EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	202388	SANDOZ