Application 210473
- Type
- ANDA
- Sponsor
- SUN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EPOPROSTENOL SODIUM | EPOPROSTENOL SODIUM | INJECTABLE;INJECTION | EQ 0.5MG BASE/VIAL | No | No |
| 002 | EPOPROSTENOL SODIUM | EPOPROSTENOL SODIUM | INJECTABLE;INJECTION | EQ 1.5MG BASE/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62756-059 | epoprostenol | epoprostenol | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-059 | epoprostenol | epoprostenol | Sun Pharmaceutical Industries Limited | ANDA | Current |
| 62756-060 | epoprostenol | epoprostenol | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-060 | epoprostenol | epoprostenol | Sun Pharmaceutical Industries Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 66061 | ORIG | 2021-02-02 |