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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210214


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NDA 210214 describes TREPROSTINIL, which is a drug marketed by Alembic Global, Dr Reddys, Ph Health, Sandoz, and Teva Pharms Usa, and is included in five NDAs. It is available from four suppliers. Additional details are available on the TREPROSTINIL profile page.

The generic ingredient in TREPROSTINIL is treprostinil. There are nineteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the treprostinil profile page.
Summary for 210214
Tradename:TREPROSTINIL
Applicant:Dr Reddys
Ingredient:treprostinil
Patents:0
Pharmacology for NDA: 210214
Physiological EffectVasodilation
Suppliers and Packaging for NDA: 210214
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TREPROSTINIL treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 210214 ANDA Dr.Reddy's Laboratories Inc., 43598-126 43598-126-11 1 VIAL in 1 CARTON (43598-126-11) / 50 mL in 1 VIAL
TREPROSTINIL treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 210214 ANDA Dr.Reddy's Laboratories Inc., 43598-646 43598-646-11 1 VIAL in 1 CARTON (43598-646-11) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength1MG/ML
Approval Date:May 22, 2020TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength2.5MG/ML
Approval Date:May 22, 2020TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength5MG/ML
Approval Date:May 22, 2020TE:APRLD:No

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