Application 021289
- Type
- BLA
- Sponsor
- FERRING
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 021289 | Bravelle | urofollitropin | 351(a) | Disc | 2026-07-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BRAVELLE | UROFOLLITROPIN | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 75 IU/VIAL | No | No |
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 1 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55566-8505 | Bravelle | Urofollitropin | Ferring Pharmaceuticals Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 66729 | ORIG | 2021-03-10 |
| 42084 | ORIG | 2020-03-23 |
| 36594 | ORIG | 2020-03-23 |
| 14903 | SUPPL | 2020-03-23 |
| 4936 | SUPPL | 2020-03-23 |
| 4935 | ORIG | 2020-03-23 |
| 66431 | APPL | 2020-03-22 |