Application 210473
- Type
- ANDA
- Sponsor
- SUN PHARM
Related Records
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 | Title | Submission type | Submission no. | Date | Storage |
|---|---|---|---|---|---|
| 66061 | 0 | ORIG | 1 | 2021-02-02 | Cached in FDA.report object storage |