Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 213913
Company: MYLAN

Products on ANDA 213913

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPOPROSTENOL SODIUM	EPOPROSTENOL SODIUM	EQ 0.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP2	No	No
EPOPROSTENOL SODIUM	EPOPROSTENOL SODIUM	EQ 1.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213913

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213913

EPOPROSTENOL SODIUM

INJECTABLE;INJECTION; EQ 0.5MG BASE/VIAL
TE Code = AP2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPOPROSTENOL SODIUM	EPOPROSTENOL SODIUM	EQ 0.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP2	213913	MYLAN
EPOPROSTENOL SODIUM	EPOPROSTENOL SODIUM	EQ 0.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP2	210473	SUN PHARM
VELETRI	EPOPROSTENOL SODIUM	EQ 0.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP2	022260	ACTELION

INJECTABLE;INJECTION; EQ 1.5MG BASE/VIAL
TE Code = AP2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPOPROSTENOL SODIUM	EPOPROSTENOL SODIUM	EQ 1.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP2	213913	MYLAN
EPOPROSTENOL SODIUM	EPOPROSTENOL SODIUM	EQ 1.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP2	210473	SUN PHARM
VELETRI	EPOPROSTENOL SODIUM	EQ 1.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP2	022260	ACTELION