Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208415
Company: AUROBINDO PHARMA LTD

Products on ANDA 208415

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LINAGLIPTIN	LINAGLIPTIN	5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208415

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/03/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208415TA_ltr.pdf

Therapeutic Equivalents for ANDA 208415

LINAGLIPTIN

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LINAGLIPTIN	LINAGLIPTIN	5MG	TABLET;ORAL	Prescription	No	AB	208415	AUROBINDO PHARMA LTD
LINAGLIPTIN	LINAGLIPTIN	5MG	TABLET;ORAL	Prescription	No	AB	208428	DR REDDYS
LINAGLIPTIN	LINAGLIPTIN	5MG	TABLET;ORAL	Prescription	No	AB	208423	INVAGEN PHARMS
LINAGLIPTIN	LINAGLIPTIN	5MG	TABLET;ORAL	Prescription	No	AB	208457	MSN
LINAGLIPTIN	LINAGLIPTIN	5MG	TABLET;ORAL	Prescription	No	AB	208431	MYLAN
LINAGLIPTIN	LINAGLIPTIN	5MG	TABLET;ORAL	Prescription	No	AB	208335	SUNSHINE
LINAGLIPTIN	LINAGLIPTIN	5MG	TABLET;ORAL	Prescription	No	AB	208448	ZYDUS PHARMS
TRADJENTA	LINAGLIPTIN	5MG	TABLET;ORAL	Prescription	Yes	AB	201280	BOEHRINGER INGELHEIM