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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210473
Company: SUN PHARM

Products on ANDA 210473

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	Yes
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 210473

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/15/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210473Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/03/2025	SUPPL-5	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 210473

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	219237	GLAND
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	219237	GLAND
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

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