Insects (Whole Body), Mite Dermatophagoides pteronyssinus Purple Book BLA 102213
- BLA number
- 102213
- Proper names
- Insects (Whole Body), Mite Dermatophagoides pteronyssinus
- Applicant
- Allermed Laboratories, 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 | | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 5,000AU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | 1974-03-12 | |
| 002 | | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 5,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | 1974-03-12 | |
| 003 | | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 5,000AU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | 1974-03-12 | |
| 004 | | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 5,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | 1974-03-12 | |
| 005 | | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 10,000AU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | 1974-03-12 | |
| 006 | | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 10,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | 1974-03-12 | |
| 007 | | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 10,000AU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | 1974-03-12 | |
| 008 | | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 10,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | 1974-03-12 | |
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 |
|---|
| 2021-05-01 | U | 001 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Allermed Laboratories, Inc. |
| 2021-05-01 | U | 002 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Allermed Laboratories, Inc. |
| 2021-05-01 | U | 003 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Allermed Laboratories, Inc. |
| 2021-05-01 | U | 004 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Allermed Laboratories, Inc. |
| 2021-05-01 | U | 005 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Allermed Laboratories, Inc. |
| 2021-05-01 | U | 006 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Allermed Laboratories, Inc. |
| 2021-05-01 | U | 007 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Allermed Laboratories, Inc. |
| 2021-05-01 | U | 008 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Allermed Laboratories, Inc. |
| 2020-08-01 | R | 001 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Allermed Laboratories, Inc. |
| 2020-08-01 | R | 002 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Allermed Laboratories, Inc. |
| 2020-08-01 | R | 003 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Allermed Laboratories, Inc. |
| 2020-08-01 | R | 004 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Allermed Laboratories, Inc. |
| 2020-08-01 | R | 005 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Allermed Laboratories, Inc. |
| 2020-08-01 | R | 006 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Allermed Laboratories, Inc. |
| 2020-08-01 | R | 007 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Allermed Laboratories, Inc. |
| 2020-08-01 | R | 008 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Allermed Laboratories, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-08-01 | 001 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Licensed | 1974-03-12 |
| 2020-08-01 | 002 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Licensed | 1974-03-12 |
| 2020-08-01 | 003 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Licensed | 1974-03-12 |
| 2020-08-01 | 004 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Licensed | 1974-03-12 |
| 2020-08-01 | 005 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Licensed | 1974-03-12 |
| 2020-08-01 | 006 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Licensed | 1974-03-12 |
| 2020-08-01 | 007 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Licensed | 1974-03-12 |
| 2020-08-01 | 008 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | Licensed | 1974-03-12 |