Details for New Drug Application (NDA): 078396
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NDA 078396 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 078396
| Tradename: | EPOPROSTENOL SODIUM |
| Applicant: | Meitheal |
| Ingredient: | epoprostenol sodium |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 078396
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.5MG BASE/VIAL | ||||
| Approval Date: | Apr 23, 2008 | TE: | AP1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1.5MG BASE/VIAL | ||||
| Approval Date: | Apr 23, 2008 | TE: | AP1 | RLD: | No | ||||
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