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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 214302


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NDA 214302 describes SELEXIPAG, which is a drug marketed by Alembic and Zydus Lifesciences and is included in two NDAs. It is available from one supplier. Additional details are available on the SELEXIPAG profile page.

The generic ingredient in SELEXIPAG is selexipag. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the selexipag profile page.
Summary for 214302
Tradename:SELEXIPAG
Applicant:Zydus Lifesciences
Ingredient:selexipag
Patents:0
Pharmacology for NDA: 214302
Mechanism of ActionProstacyclin Receptor Agonists
Suppliers and Packaging for NDA: 214302
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SELEXIPAG selexipag TABLET;ORAL 214302 ANDA Zydus Pharmaceuticals (USA) Inc. 70710-1551 70710-1551-6 60 TABLET, FILM COATED in 1 BOTTLE (70710-1551-6)
SELEXIPAG selexipag TABLET;ORAL 214302 ANDA Zydus Pharmaceuticals (USA) Inc. 70710-1551 70710-1551-8 140 TABLET, FILM COATED in 1 BOTTLE (70710-1551-8)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.2MG
Approval Date:Dec 21, 2022TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.4MG
Approval Date:Dec 21, 2022TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.6MG
Approval Date:Dec 21, 2022TE:RLD:No

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Preferred Citation:

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