Skip to content
Application 020497
- Type
- NDA
- Sponsor
- KYOWA KIRIN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FARESTON | TOREMIFENE CITRATE | TABLET;ORAL | EQ 60MG BASE | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42747-327 | Fareston | toremifene citrate | KYOWA KIRIN, INC, | NDA | Current |
| 42747-327 | Fareston | toremifene citrate | KYOWA KIRIN, INC, | NDA | Current |
| 42747-327 | Fareston | toremifene citrate | KYOWA KIRIN, INC, | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80589 | SUPPL | 2024-12-16 |
| 80579 | SUPPL | 2024-12-16 |
| 61525 | SUPPL | 2020-01-07 |
| 48405 | SUPPL | 2017-05-17 |
| 48369 | SUPPL | 2017-05-15 |
| 12638 | SUPPL | 2011-03-28 |
| 2604 | SUPPL | 2011-03-24 |