Details for New Drug Application (NDA): 206648

NDA 206648 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 206648

Tradename:	TREPROSTINIL
Applicant:	Teva Pharms Usa
Ingredient:	treprostinil
Patents:	0

Pharmacology for NDA: 206648

Physiological Effect

Vasodilation

Suppliers and Packaging for NDA: 206648

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TREPROSTINIL	treprostinil	INJECTABLE;IV (INFUSION), 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;IV (INFUSION), 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:	RX	Dosage:	INJECTABLE;IV (INFUSION), SUBCUTANEOUS			Strength	1MG/ML
Approval Date:	Sep 26, 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 26, 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 26, 2019	TE:	AP	RLD:	No

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