Details for New Drug Application (NDA): 219237
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NDA 219237 describes EPOPROSTENOL SODIUM, which is a drug marketed by Gland, Meitheal, Mylan, and Sun Pharm, and is included in four NDAs. It is available from three 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the epoprostenol sodium profile page.
Summary for 219237
| Tradename: | EPOPROSTENOL SODIUM |
| Applicant: | Gland |
| Ingredient: | epoprostenol sodium |
| Patents: | 0 |
Pharmacology for NDA: 219237
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 219237
Suppliers and Packaging for NDA: 219237
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 219237 | ANDA | Gland Pharma Limited | 68083-642 | 68083-642-01 | 1 VIAL in 1 CARTON (68083-642-01) / 10 mL in 1 VIAL |
| EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 219237 | ANDA | Gland Pharma Limited | 68083-707 | 68083-707-01 | 1 VIAL in 1 CARTON (68083-707-01) / 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: | Dec 29, 2025 | 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: | Dec 29, 2025 | TE: | AP2 | RLD: | No | ||||
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