Last Updated: May 3, 2026

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. It is available from one supplier. 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

Pharmacology for NDA: 208335

Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Medical Subject Heading (MeSH) Categories for 208335

Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Incretins

Suppliers and Packaging for NDA: 208335

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LINAGLIPTIN	linagliptin	TABLET;ORAL	208335	ANDA	Sunshine Lake Pharma Co., Ltd.	48792-7865	48792-7865-1	30 TABLET, FILM COATED in 1 BOTTLE (48792-7865-1)

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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