Novarel Purple Book BLA 017016
- BLA number
- 017016
- Proprietary names
- Novarel
- Proper names
- chorionic gonadotropin
- Applicant
- Ferring Pharmaceuticals Inc.
- Center
- CDER
- First observed release
- 2020-05-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 004 | Novarel | chorionic gonadotropin | 351(a) | 20,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | 1974-01-15 | |
| 006 | Novarel | chorionic gonadotropin | 351(a) | 5,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Rx | Licensed | 1974-01-15 | |
| 007 | Novarel | chorionic gonadotropin | 351(a) | 10,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | 1974-01-15 | |
| 009 | Novarel | chorionic gonadotropin | 351(a) | 2,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | 1984-12-27 | |
| 010 | Novarel | chorionic gonadotropin | 351(a) | 15,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | 1985-02-15 | |
| 011 | Novarel | chorionic gonadotropin | 351(a) | 2,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | 1990-02-16 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2023-07-01 | U | 007 | Novarel | 351(a) | Disc | Ferring Pharmaceuticals Inc. |
| 2020-11-01 | U | 010 | Novarel | 351(a) | Disc | Ferring Pharmaceuticals Inc. |
| 2020-05-01 | R | 004 | Novarel | 351(a) | Disc | Ferring Pharmaceuticals Inc. |
| 2020-05-01 | R | 006 | Novarel | 351(a) | Rx | Ferring Pharmaceuticals Inc. |
| 2020-05-01 | R | 007 | Novarel | 351(a) | Rx | Ferring Pharmaceuticals Inc. |
| 2020-05-01 | R | 009 | Novarel | 351(a) | Disc | Ferring Pharmaceuticals Inc. |
| 2020-05-01 | R | 010 | Novarel | 351(a) | Disc | Ferring Pharmaceuticals Inc. |
| 2020-05-01 | R | 011 | Novarel | 351(a) | Disc | Ferring Pharmaceuticals Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2023-07-01 | 007 | Novarel | 351(a) | Disc | Licensed | 1974-01-15 |
| 2020-05-01 | 004 | Novarel | 351(a) | Disc | Licensed | 1974-01-15 |
| 2020-05-01 | 006 | Novarel | 351(a) | Rx | Licensed | 1974-01-15 |
| 2020-05-01 | 007 | Novarel | 351(a) | Rx | Licensed | 1974-01-15 |
| 2020-05-01 | 009 | Novarel | 351(a) | Disc | Licensed | 1984-12-27 |
| 2020-05-01 | 010 | Novarel | 351(a) | Disc | Licensed | 1985-02-15 |
| 2020-05-01 | 011 | Novarel | 351(a) | Disc | Licensed | 1990-02-16 |