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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208449
Company: ZYDUS PHARMS

Products on ANDA 208449

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Prescription	AB	No	No
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;850MG	TABLET;ORAL	Prescription	AB	No	No
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208449

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208449Orig1s000TALtr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/11/2026	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 208449

LINAGLIPTIN AND METFORMIN HYDROCHLORIDE

TABLET;ORAL; 2.5MG;500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
JENTADUETO	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Prescription	Yes	AB	201281	BOEHRINGER INGELHEIM
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Prescription	No	AB	208427	DR REDDYS
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Prescription	No	AB	208459	MSN
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Prescription	No	AB	208336	SUNSHINE
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Prescription	No	AB	208449	ZYDUS PHARMS

TABLET;ORAL; 2.5MG;850MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
JENTADUETO	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;850MG	TABLET;ORAL	Prescription	Yes	AB	201281	BOEHRINGER INGELHEIM
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;850MG	TABLET;ORAL	Prescription	No	AB	208427	DR REDDYS
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;850MG	TABLET;ORAL	Prescription	No	AB	208459	MSN
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;850MG	TABLET;ORAL	Prescription	No	AB	208336	SUNSHINE
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;850MG	TABLET;ORAL	Prescription	No	AB	208449	ZYDUS PHARMS

TABLET;ORAL; 2.5MG;1GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
JENTADUETO	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET;ORAL	Prescription	Yes	AB	201281	BOEHRINGER INGELHEIM
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET;ORAL	Prescription	No	AB	208427	DR REDDYS
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET;ORAL	Prescription	No	AB	208459	MSN
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET;ORAL	Prescription	No	AB	208336	SUNSHINE
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET;ORAL	Prescription	No	AB	208449	ZYDUS PHARMS

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