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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 210473


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NDA 210473 describes EPOPROSTENOL SODIUM, which is a drug marketed by Meitheal and Sun Pharm and is included in two NDAs. It is available from one supplier. Additional details are available on the EPOPROSTENOL SODIUM profile page.

The generic ingredient in EPOPROSTENOL SODIUM is epoprostenol sodium. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the epoprostenol sodium profile page.
Summary for 210473
Tradename:EPOPROSTENOL SODIUM
Applicant:Sun Pharm
Ingredient:epoprostenol sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210473
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 210473
Suppliers and Packaging for NDA: 210473
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 210473 ANDA Sun Pharmaceutical Industries, Inc. 62756-059 62756-059-40 1 VIAL in 1 CARTON (62756-059-40) / 10 mL in 1 VIAL
EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 210473 ANDA Sun Pharmaceutical Industries, Inc. 62756-060 62756-060-40 1 VIAL in 1 CARTON (62756-060-40) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.5MG BASE/VIAL
Approval Date:Jan 15, 2021TE:AP2RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1.5MG BASE/VIAL
Approval Date:Jan 15, 2021TE:AP2RLD:No

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