Details for New Drug Application (NDA): 210214

NDA 210214 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 210214

Tradename:	TREPROSTINIL
Applicant:	Dr Reddys
Ingredient:	treprostinil
Patents:	0

Pharmacology for NDA: 210214

Physiological Effect

Vasodilation

Suppliers and Packaging for NDA: 210214

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TREPROSTINIL	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	210214	ANDA	Dr.Reddy's Laboratories Inc.,	43598-126	43598-126-11	1 VIAL in 1 CARTON (43598-126-11) / 50 mL in 1 VIAL
TREPROSTINIL	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	210214	ANDA	Dr.Reddy's Laboratories Inc.,	43598-646	43598-646-11	1 VIAL in 1 CARTON (43598-646-11) / 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:	May 22, 2020	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:	May 22, 2020	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;IV (INFUSION), SUBCUTANEOUS			Strength	5MG/ML
Approval Date:	May 22, 2020	TE:	AP	RLD:	No

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