Details for New Drug Application (NDA): 211574

NDA 211574 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 211574

Tradename:	TREPROSTINIL
Applicant:	Alembic Global
Ingredient:	treprostinil
Patents:	0

Pharmacology for NDA: 211574

Physiological Effect

Vasodilation

Suppliers and Packaging for NDA: 211574

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TREPROSTINIL	treprostinil	INJECTABLE;IV (INFUSION), 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;IV (INFUSION), 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:	RX	Dosage:	INJECTABLE;IV (INFUSION), SUBCUTANEOUS			Strength	1MG/ML
Approval Date:	Feb 11, 2021	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:	Feb 11, 2021	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;IV (INFUSION), SUBCUTANEOUS			Strength	5MG/ML
Approval Date:	Feb 11, 2021	TE:	AP	RLD:	No

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