Nutropin AQ Purple Book BLA 020522
- BLA number
- 020522
- Proprietary names
- Nutropin AQ
- Proper names
- somatropin
- Applicant
- Genentech, 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 |
|---|
| 001 | Nutropin AQ | somatropin | 351(a) | 10MG/2ML | Injection | Subcutaneous | Vial | Disc | Voluntarily Revoked | 1995-12-29 | |
| 002 | Nutropin AQ | somatropin | 351(a) | 10MG/2ML | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | Voluntarily Revoked | 2002-04-22 | |
| 003 | Nutropin AQ | somatropin | 351(a) | 5MG/2ML | Injection | Subcutaneous | Autoinjector | Disc | Voluntarily Revoked | 2008-01-03 | |
| 004 | Nutropin AQ | somatropin | 351(a) | 20MG/2ML | Injection | Subcutaneous | Autoinjector | Disc | Voluntarily Revoked | 2008-01-03 | |
| 005 | Nutropin AQ | somatropin | 351(a) | 10MG/2ML | Injection | Subcutaneous | Autoinjector | Disc | Voluntarily Revoked | 2008-01-03 | |
| 006 | Nutropin AQ | somatropin | 351(a) | 20MG/2ML | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | Voluntarily Revoked | 2008-01-03 | |
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 |
|---|
| 2025-09-01 | U | 001 | Nutropin AQ | 351(a) | Disc | Genentech, Inc. |
| 2025-09-01 | U | 002 | Nutropin AQ | 351(a) | Disc | Genentech, Inc. |
| 2025-09-01 | U | 003 | Nutropin AQ | 351(a) | Disc | Genentech, Inc. |
| 2025-09-01 | U | 004 | Nutropin AQ | 351(a) | Disc | Genentech, Inc. |
| 2025-09-01 | U | 005 | Nutropin AQ | 351(a) | Disc | Genentech, Inc. |
| 2025-09-01 | U | 006 | Nutropin AQ | 351(a) | Disc | Genentech, Inc. |
| 2021-04-01 | U | 002 | Nutropin AQ | 351(a) | Disc | Genentech, Inc. |
| 2021-04-01 | U | 003 | Nutropin AQ | 351(a) | Rx | Genentech, Inc. |
| 2021-04-01 | U | 004 | Nutropin AQ | 351(a) | Rx | Genentech, Inc. |
| 2021-04-01 | U | 005 | Nutropin AQ | 351(a) | Rx | Genentech, Inc. |
| 2021-04-01 | U | 006 | Nutropin AQ | 351(a) | Disc | Genentech, Inc. |
| 2020-05-01 | R | 001 | Nutropin AQ | 351(a) | Disc | Genentech, Inc. |
| 2020-05-01 | R | 002 | Nutropin AQ | 351(a) | Disc | Genentech, Inc. |
| 2020-05-01 | R | 003 | Nutropin AQ | 351(a) | Rx | Genentech, Inc. |
| 2020-05-01 | R | 004 | Nutropin AQ | 351(a) | Rx | Genentech, Inc. |
| 2020-05-01 | R | 005 | Nutropin AQ | 351(a) | Rx | Genentech, Inc. |
| 2020-05-01 | R | 006 | Nutropin AQ | 351(a) | Disc | Genentech, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2025-09-01 | 001 | Nutropin AQ | 351(a) | Disc | Voluntarily Revoked | 1995-12-29 |
| 2025-09-01 | 002 | Nutropin AQ | 351(a) | Disc | Voluntarily Revoked | 2002-04-22 |
| 2025-09-01 | 003 | Nutropin AQ | 351(a) | Disc | Voluntarily Revoked | 2008-01-03 |
| 2025-09-01 | 004 | Nutropin AQ | 351(a) | Disc | Voluntarily Revoked | 2008-01-03 |
| 2025-09-01 | 005 | Nutropin AQ | 351(a) | Disc | Voluntarily Revoked | 2008-01-03 |
| 2025-09-01 | 006 | Nutropin AQ | 351(a) | Disc | Voluntarily Revoked | 2008-01-03 |
| 2020-05-01 | 001 | Nutropin AQ | 351(a) | Disc | Licensed | 1995-12-29 |
| 2020-05-01 | 002 | Nutropin AQ | 351(a) | Disc | Licensed | 2002-04-22 |
| 2020-05-01 | 003 | Nutropin AQ | 351(a) | Rx | Licensed | 2008-01-03 |
| 2020-05-01 | 004 | Nutropin AQ | 351(a) | Rx | Licensed | 2008-01-03 |
| 2020-05-01 | 005 | Nutropin AQ | 351(a) | Rx | Licensed | 2008-01-03 |
| 2020-05-01 | 006 | Nutropin AQ | 351(a) | Disc | Licensed | 2008-01-03 |