Details for New Drug Application (NDA): 213913
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NDA 213913 describes EPOPROSTENOL SODIUM, which is a drug marketed by Meitheal, Mylan, and Sun Pharm, and is included in three NDAs. It is available from two suppliers. 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. Four suppliers are listed for this compound. 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. Four suppliers are listed for this compound. Additional details are available on the epoprostenol sodium profile page.
Summary for 213913
| Tradename: | EPOPROSTENOL SODIUM |
| Applicant: | Mylan |
| Ingredient: | epoprostenol sodium |
| Patents: | 0 |
Pharmacology for NDA: 213913
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 213913
Suppliers and Packaging for NDA: 213913
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 213913 | ANDA | Mylan Institutional LLC | 67457-587 | 67457-587-10 | 1 VIAL in 1 CARTON (67457-587-10) / 10 mL in 1 VIAL |
| EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 213913 | ANDA | Mylan Institutional LLC | 67457-588 | 67457-588-10 | 1 VIAL in 1 CARTON (67457-588-10) / 10 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.5MG BASE/VIAL | ||||
| Approval Date: | Jun 12, 2024 | TE: | AP2 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1.5MG BASE/VIAL | ||||
| Approval Date: | Jun 12, 2024 | TE: | AP2 | RLD: | No | ||||
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