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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 203649


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NDA 203649 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 203649
Tradename:TREPROSTINIL
Applicant:Sandoz
Ingredient:treprostinil
Patents:0
Pharmacology for NDA: 203649
Physiological EffectVasodilation
Suppliers and Packaging for NDA: 203649
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TREPROSTINIL treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 203649 ANDA Sandoz Inc 0781-3420 0781-3420-80 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3420-80) / 20 mL in 1 VIAL, MULTI-DOSE
TREPROSTINIL treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 203649 ANDA Sandoz Inc 0781-3425 0781-3425-80 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3425-80) / 20 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength1MG/ML
Approval Date:Nov 30, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength2.5MG/ML
Approval Date:Nov 30, 2017TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength5MG/ML
Approval Date:Nov 30, 2017TE:APRLD:No

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Preferred Citation:

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