Aplisol Purple Book BLA 103782
- BLA number
- 103782
- Proprietary names
- Aplisol
- Proper names
- Tuberculin, Purified Protein Derivative
- Applicant
- Endo Operations Limited, Par Pharmaceutical Companies, Inc.
- Center
- CBER
- First observed release
- 2020-08-01
- 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 | Aplisol | Tuberculin, Purified Protein Derivative | 351(a) | 5TU/.1ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | 1998-04-20 | |
| 002 | Aplisol | Tuberculin, Purified Protein Derivative | 351(a) | 250TU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | 1998-04-20 | |
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 |
|---|
| 2024-07-01 | U | 001 | Aplisol | 351(a) | Rx | Endo Operations Limited |
| 2022-01-01 | U | 001 | Aplisol | 351(a) | Rx | Par Pharmaceutical Companies, Inc. |
| 2021-09-01 | U | 001 | Aplisol | 351(a) | Rx | Par Pharmaceutical Companies, Inc. |
| 2021-05-01 | U | 001 | Aplisol | 351(a) | Rx | Par Pharmaceutical Companies, Inc. |
| 2021-05-01 | U | 002 | Aplisol | 351(a) | Rx | Par Pharmaceutical Companies, Inc. |
| 2020-08-01 | R | 001 | Aplisol | 351(a) | Rx | Par Pharmaceutical Companies, Inc. |
| 2020-08-01 | R | 002 | Aplisol | 351(a) | Rx | Par Pharmaceutical Companies, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-08-01 | 001 | Aplisol | 351(a) | Rx | Licensed | 1998-04-20 |
| 2020-08-01 | 002 | Aplisol | 351(a) | Rx | Licensed | 1998-04-20 |