Application 021047
- Type
- BLA
- Sponsor
- FERRING
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 021047 | Repronex | menotropins | 351(a) | Disc | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | REPRONEX | MENOTROPINS (FSH;LH) | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 75 IU/VIAL;75 IU/VIAL | No | No |
| 002 | REPRONEX | MENOTROPINS (FSH;LH) | INJECTABLE;INJECTION | 150 IU/VIAL;150 IU/VIAL | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 66393 | SUPPL | 2021-02-26 |
| 66318 | ORIG | 2021-02-22 |
| 66388 | APPL | 2020-03-23 |
| 41905 | SUPPL | 2020-03-23 |
| 35981 | ORIG | 2020-03-23 |
| 26592 | ORIG | 2020-03-23 |
| 21390 | ORIG | 2020-03-23 |