Details for New Drug Application (NDA): 210473
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NDA 210473 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 210473
| Tradename: | EPOPROSTENOL SODIUM |
| Applicant: | Sun Pharm |
| Ingredient: | epoprostenol sodium |
| Patents: | 0 |
Pharmacology for NDA: 210473
| Physiological Effect | Vasodilation |
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: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.5MG BASE/VIAL | ||||
| Approval Date: | Jan 15, 2021 | 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: | Jan 15, 2021 | TE: | AP2 | RLD: | No | ||||
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