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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202426
Company: APOTEX

Products on ANDA 202426

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 202426

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2026	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 202426

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	202426	APOTEX
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	202426	APOTEX
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	1GM;EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	202388	SANDOZ

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