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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 211574


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NDA 211574 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 211574
Tradename:TREPROSTINIL
Applicant:Alembic Global
Ingredient:treprostinil
Patents:0
Pharmacology for NDA: 211574
Physiological EffectVasodilation
Suppliers and Packaging for NDA: 211574
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TREPROSTINIL treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 211574 ANDA Alembic Pharmaceuticals Inc. 62332-514 62332-514-20 1 VIAL in 1 CARTON (62332-514-20) / 20 mL in 1 VIAL
TREPROSTINIL treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 211574 ANDA Alembic Pharmaceuticals Inc. 62332-515 62332-515-20 1 VIAL in 1 CARTON (62332-515-20) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength1MG/ML
Approval Date:Feb 11, 2021TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength2.5MG/ML
Approval Date:Feb 11, 2021TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength5MG/ML
Approval Date:Feb 11, 2021TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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