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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 206648


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NDA 206648 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 206648
Tradename:TREPROSTINIL
Applicant:Teva Pharms Usa
Ingredient:treprostinil
Patents:0
Pharmacology for NDA: 206648
Physiological EffectVasodilation
Suppliers and Packaging for NDA: 206648
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TREPROSTINIL treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 206648 ANDA Teva Parenteral Medicines, Inc. 0703-0666 0703-0666-01 1 VIAL, MULTI-DOSE in 1 CARTON (0703-0666-01) / 20 mL in 1 VIAL, MULTI-DOSE
TREPROSTINIL treprostinil INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 206648 ANDA Teva Parenteral Medicines, Inc. 0703-0676 0703-0676-01 1 VIAL, MULTI-DOSE in 1 CARTON (0703-0676-01) / 20 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength1MG/ML
Approval Date:Sep 26, 2019TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength2.5MG/ML
Approval Date:Sep 26, 2019TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength5MG/ML
Approval Date:Sep 26, 2019TE:APRLD:No

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Preferred Citation:

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