Details for New Drug Application (NDA): 209382

NDA 209382 describes TREPROSTINIL, which is a drug marketed by Alembic Global, Dr Reddys, Endo Operations, Sandoz, and Teva Pharms Usa, and is included in five NDAs. It is available from five 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. Six suppliers are listed for this compound. Additional details are available on the treprostinil profile page.

Summary for 209382

Tradename:	TREPROSTINIL
Applicant:	Endo Operations
Ingredient:	treprostinil
Patents:	0

Pharmacology for NDA: 209382

Physiological Effect

Vasodilation

Suppliers and Packaging for NDA: 209382

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TREPROSTINIL	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	209382	ANDA	Endo USA, Inc.	42023-206	42023-206-01	1 VIAL in 1 CARTON (42023-206-01) / 20 mL in 1 VIAL
TREPROSTINIL	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	209382	ANDA	Endo USA, Inc.	42023-207	42023-207-01	1 VIAL in 1 CARTON (42023-207-01) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;IV (INFUSION), SUBCUTANEOUS			Strength	1MG/ML
Approval Date:	Sep 24, 2019	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;IV (INFUSION), SUBCUTANEOUS			Strength	2.5MG/ML
Approval Date:	Sep 24, 2019	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;IV (INFUSION), SUBCUTANEOUS			Strength	5MG/ML
Approval Date:	Sep 24, 2019	TE:	AP	RLD:	No

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