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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 208459


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NDA 208459 describes LINAGLIPTIN AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Dr Reddys, MSN, Sunshine, and Zydus Pharms, and is included in four NDAs. It is available from one supplier. Additional details are available on the LINAGLIPTIN AND METFORMIN HYDROCHLORIDE profile page.

The generic ingredient in LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 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 208459
Tradename:LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
Applicant:Msn
Ingredient:linagliptin; metformin hydrochloride
Patents:0
Pharmacology for NDA: 208459
Mechanism of ActionDipeptidyl Peptidase 4 Inhibitors
Suppliers and Packaging for NDA: 208459
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE linagliptin; metformin hydrochloride TABLET;ORAL 208459 ANDA Novadoz Pharmaceuticals LLC 72205-407 72205-407-01 60 TABLET, FILM COATED in 1 BOTTLE (72205-407-01)
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE linagliptin; metformin hydrochloride TABLET;ORAL 208459 ANDA Novadoz Pharmaceuticals LLC 72205-407 72205-407-02 180 TABLET, FILM COATED in 1 BOTTLE (72205-407-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;500MG
Approval Date:Nov 3, 2025TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;850MG
Approval Date:Nov 3, 2025TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;1GM
Approval Date:Nov 3, 2025TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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