FDA Approved Products

Application #	Type	Sponsor	Product #	Drug Name	Form	Strength	Active Ingredient	Approval Date	Marketing Status	Reference Standard
214324	NDA	UNITED THERAP	001	TYVASO DPI	POWDER;INHALATION	0.016MG/INH	TREPROSTINIL	2022-05-23	Prescription	Yes
			002	TYVASO DPI	POWDER;INHALATION	0.032MG/INH	TREPROSTINIL	2022-05-23	Prescription	Yes
			003	TYVASO DPI	POWDER;INHALATION	0.048MG/INH	TREPROSTINIL	2022-05-23	Prescription	Yes
			004	TYVASO DPI	POWDER;INHALATION	0.064MG/INH	TREPROSTINIL	2022-05-23	Prescription	Yes
			005	TYVASO DPI	POWDER;INHALATION	0.08MG/INH	TREPROSTINIL	2022-05-23	Prescription	Yes
213456	ANDA	UNITED RES LABS	001	COLESEVELAM HYDROCHLORIDE	TABLET;ORAL	625MG	COLESEVELAM HYDROCHLORIDE	2022-01-21	Discontinued	No
208276	NDA	UNITED THERAP	001	REMODULIN	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	20MG/20ML (1MG/ML)	TREPROSTINIL	2018-07-30	Discontinued	No
			002	REMODULIN	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	50MG/20ML (2.5MG/ML)	TREPROSTINIL	2018-07-30	Discontinued	No
			003	REMODULIN	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	100MG/20ML (5MG/ML)	TREPROSTINIL	2018-07-30	Discontinued	No
			004	REMODULIN	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	200MG/20ML (10MG/ML)	TREPROSTINIL	2018-07-30	Discontinued	No
125516	BLA	UNITED THERAP	001	UNITUXIN	INJECTABLE;INTRAVENOUS	17.5MG/5ML	DINUTUXIMAB	2015-03-10	Prescription	No
203496	NDA	UNITED THERAP	001	ORENITRAM	TABLET, EXTENDED RELEASE;ORAL	EQ 0.125MG BASE	TREPROSTINIL DIOLAMINE	2013-12-20	Prescription	No
			002	ORENITRAM	TABLET, EXTENDED RELEASE;ORAL	EQ 0.25MG BASE	TREPROSTINIL DIOLAMINE	2013-12-20	Prescription	No
			003	ORENITRAM	TABLET, EXTENDED RELEASE;ORAL	EQ 1MG BASE	TREPROSTINIL DIOLAMINE	2013-12-20	Prescription	Yes
			004	ORENITRAM	TABLET, EXTENDED RELEASE;ORAL	EQ 2.5MG BASE	TREPROSTINIL DIOLAMINE	2013-12-20	Prescription	No
			005	ORENITRAM	TABLET, EXTENDED RELEASE;ORAL	EQ 5MG BASE	TREPROSTINIL DIOLAMINE	2013-12-20	Prescription	No
022387	NDA	UNITED THERAP	001	TYVASO	SOLUTION;INHALATION	0.6MG/ML	TREPROSTINIL	2009-07-30	Prescription	Yes
021272	NDA	UNITED THERAP	001	REMODULIN	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	1MG/ML	TREPROSTINIL	2002-05-21	Prescription	Yes
			002	REMODULIN	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	2.5MG/ML	TREPROSTINIL	2002-05-21	Prescription	Yes
			003	REMODULIN	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	5MG/ML	TREPROSTINIL	2002-05-21	Prescription	Yes
			004	REMODULIN	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	10MG/ML	TREPROSTINIL	2002-05-21	Prescription	Yes
			005	REMODULIN	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	20MG/ML	TREPROSTINIL	2002-05-21	Discontinued	No
			006	REMODULIN	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	0.1MG/ML	TREPROSTINIL	2002-05-21	Discontinued	No
			007	REMODULIN	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	0.2MG/ML	TREPROSTINIL	2002-05-21	Discontinued	No
			008	REMODULIN	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	0.4MG/ML	TREPROSTINIL	2002-05-21	Prescription	Yes