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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 208335

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NDA 208335 describes LINAGLIPTIN, which is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys, Invagen Pharms, MSN, Mylan, Sunshine, and Zydus Pharms, and is included in eleven NDAs. Additional details are available on the LINAGLIPTIN profile page.

The generic ingredient in LINAGLIPTIN is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.

Summary for 208335

Tradename:	LINAGLIPTIN
Applicant:	Sunshine
Ingredient:	linagliptin
Patents:	0

Medical Subject Heading (MeSH) Categories for 208335

Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Incretins

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Aug 31, 2021	TE:	AB	RLD:	No

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