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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078396
Company: MEITHEAL

Products on ANDA 078396

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	AP1	No	No
EPOPROSTENOL SODIUM	EPOPROSTENOL SODIUM	EQ 1.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078396

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2008	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078396s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/09/2022	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
06/09/2022	SUPPL-22	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
06/09/2022	SUPPL-21	Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
04/29/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078396

EPOPROSTENOL SODIUM

INJECTABLE;INJECTION; EQ 0.5MG BASE/VIAL
TE Code = AP1

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	AP1	078396	MEITHEAL
FLOLAN	EPOPROSTENOL SODIUM	EQ 0.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP1	020444	GLAXOSMITHKLINE LLC

INJECTABLE;INJECTION; EQ 1.5MG BASE/VIAL
TE Code = AP1

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	AP1	078396	MEITHEAL
FLOLAN	EPOPROSTENOL SODIUM	EQ 1.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP1	020444	GLAXOSMITHKLINE LLC

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