Application 203505
- Type
- NDA
- Sponsor
- DUCHESNAY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OSPHENA | OSPEMIFENE | TABLET;ORAL | 60MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59630-580 | Osphena | Ospemifene | Shionogi Inc. | NDA | Current |
| 59630-580 | Osphena | Ospemifene | Shionogi Inc. | NDA | Current |
| 59630-580 | Osphena | Ospemifene | Shionogi Inc. | NDA | Current |
| 59630-580 | Osphena | Ospemifene | Shionogi Inc. | NDA | Current |
| 59630-580 | Osphena | Ospemifene | Shionogi Inc. | NDA | Current |
| 75929-178 | Osphena | Ospemifene | Pharma Packaging Solutions | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81213 | SUPPL | 2025-02-11 |
| 81178 | SUPPL | 2025-02-10 |
| 77572 | SUPPL | 2024-02-20 |
| 77550 | SUPPL | 2024-02-16 |
| 57536 | SUPPL | 2019-02-13 |
| 57354 | SUPPL | 2019-01-28 |
| 56190 | SUPPL | 2018-10-30 |
| 56149 | SUPPL | 2018-10-29 |
| 40308 | SUPPL | 2015-03-02 |
| 32434 | SUPPL | 2015-02-27 |
| 43438 | ORIG | 2013-03-28 |
| 40307 | ORIG | 2013-03-01 |
| 10228 | ORIG | 2013-02-28 |