Intron A Purple Book BLA 103132
- BLA number
- 103132
- Proprietary names
- Intron A
- Proper names
- interferon alfa-2b
- Applicant
- Merck Sharp & Dohme LLC
- 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 | Intron A | interferon alfa-2b | 351(a) | 3MIU | For Injection | Intramuscular, Intravenous, Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | 1986-06-04 | |
| 002 | Intron A | interferon alfa-2b | 351(a) | 5MIU | For Injection | Intramuscular, Intravenous, Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | 1986-06-04 | |
| 003 | Intron A | interferon alfa-2b | 351(a) | 10MIU | For Injection | Subcutaneous, Intravenous, Intralesional, Intramuscular | Single-Dose Vial | Disc | Voluntarily Revoked | 1986-06-04 | |
| 004 | Intron A | interferon alfa-2b | 351(a) | 25MIU | For Injection | Intramuscular, Intravenous, Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | 1986-06-04 | |
| 005 | Intron A | interferon alfa-2b | 351(a) | 18MIU | For Injection | Intramuscular, Intravenous, Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | | |
| 006 | Intron A | interferon alfa-2b | 351(a) | 50MIU | For Injection | Intramuscular, Intravenous, Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | | |
| 007 | Intron A | interferon alfa-2b | 351(a) | 3MIU | Injection | Subcutaneous, Intramuscular | Single-Dose Vial | Disc | Voluntarily Revoked | | |
| 008 | Intron A | interferon alfa-2b | 351(a) | 5MIU | Injection | Intralesional, Intramuscular, Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | | |
| 009 | Intron A | interferon alfa-2b | 351(a) | 10MIU | Injection | Intralesional, Intramuscular, Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | | |
| 010 | Intron A | interferon alfa-2b | 351(a) | 18MIU | Injection | Subcutaneous, Intramuscular | Multi-Dose Vial | Disc | Voluntarily Revoked | | |
| 011 | Intron A | interferon alfa-2b | 351(a) | 25MIU | Injection | Intralesional, Intramuscular, Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | | |
| 012 | Intron A | interferon alfa-2b | 351(a) | 3MIU | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Voluntarily Revoked | | |
| 013 | Intron A | interferon alfa-2b | 351(a) | 5MIU | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Voluntarily Revoked | | |
| 014 | Intron A | interferon alfa-2b | 351(a) | 10MIU | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Voluntarily Revoked | | |
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 |
|---|
| 2023-04-01 | U | 001 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-04-01 | U | 002 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-04-01 | U | 003 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-04-01 | U | 004 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-04-01 | U | 005 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-04-01 | U | 006 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-04-01 | U | 007 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-04-01 | U | 008 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-04-01 | U | 009 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-04-01 | U | 010 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-04-01 | U | 011 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-04-01 | U | 012 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-04-01 | U | 013 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-04-01 | U | 014 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-03-01 | U | 001 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-03-01 | U | 002 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-03-01 | U | 003 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-03-01 | U | 004 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-03-01 | U | 005 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-03-01 | U | 006 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-03-01 | U | 007 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-03-01 | U | 008 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-03-01 | U | 009 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-03-01 | U | 010 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-03-01 | U | 011 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-03-01 | U | 012 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-03-01 | U | 013 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-03-01 | U | 014 | Intron A | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2022-11-01 | U | 003 | Intron A | 351(a) | Disc | Merck Sharp & Dohme Corp. |
| 2022-11-01 | U | 005 | Intron A | 351(a) | Disc | Merck Sharp & Dohme Corp. |
| 2022-11-01 | U | 006 | Intron A | 351(a) | Disc | Merck Sharp & Dohme Corp. |
| 2022-11-01 | U | 010 | Intron A | 351(a) | Disc | Merck Sharp & Dohme Corp. |
| 2022-11-01 | U | 011 | Intron A | 351(a) | Disc | Merck Sharp & Dohme Corp. |
| 2022-03-01 | U | 001 | Intron A | 351(a) | Disc | Merck Sharp & Dohme Corp. |
| 2022-03-01 | U | 002 | Intron A | 351(a) | Disc | Merck Sharp & Dohme Corp. |
| 2022-03-01 | U | 003 | Intron A | 351(a) | Rx | Merck Sharp & Dohme Corp. |
| 2022-03-01 | U | 004 | Intron A | 351(a) | Disc | Merck Sharp & Dohme Corp. |
| 2022-03-01 | U | 005 | Intron A | 351(a) | Rx | Merck Sharp & Dohme Corp. |
| 2022-03-01 | U | 006 | Intron A | 351(a) | Rx | Merck Sharp & Dohme Corp. |
| 2022-03-01 | U | 007 | Intron A | 351(a) | Disc | Merck Sharp & Dohme Corp. |
| 2022-03-01 | U | 008 | Intron A | 351(a) | Disc | Merck Sharp & Dohme Corp. |
| 2022-03-01 | U | 009 | Intron A | 351(a) | Disc | Merck Sharp & Dohme Corp. |
| 2022-03-01 | U | 010 | Intron A | 351(a) | Rx | Merck Sharp & Dohme Corp. |
| 2022-03-01 | U | 011 | Intron A | 351(a) | Rx | Merck Sharp & Dohme Corp. |
| 2022-03-01 | U | 012 | Intron A | 351(a) | Disc | Merck Sharp & Dohme Corp. |
| 2022-03-01 | U | 013 | Intron A | 351(a) | Disc | Merck Sharp & Dohme Corp. |
| 2022-03-01 | U | 014 | Intron A | 351(a) | Disc | Merck Sharp & Dohme Corp. |
| 2020-08-01 | U | 001 | Intron A | 351(a) | Rx | Merck Sharp & Dohme Corp. |
| 2020-08-01 | U | 002 | Intron A | 351(a) | Rx | Merck Sharp & Dohme Corp. |
| 2020-08-01 | U | 003 | Intron A | 351(a) | Rx | Merck Sharp & Dohme Corp. |
| 2020-08-01 | U | 004 | Intron A | 351(a) | Rx | Merck Sharp & Dohme Corp. |
| 2020-08-01 | U | 005 | Intron A | 351(a) | Rx | Merck Sharp & Dohme Corp. |
| 2020-05-01 | R | 001 | Intron A | 351(a) | Rx | Merck Sharp & Dohme Corp. |
| 2020-05-01 | R | 002 | Intron A | 351(a) | Rx | Merck Sharp & Dohme Corp. |
| 2020-05-01 | R | 003 | Intron A | 351(a) | Rx | Merck Sharp & Dohme Corp. |
| 2020-05-01 | R | 004 | Intron A | 351(a) | Rx | Merck Sharp & Dohme Corp. |
| 2020-05-01 | R | 005 | Intron A | 351(a) | Rx | Merck Sharp & Dohme Corp. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2023-04-01 | 001 | Intron A | 351(a) | Disc | Voluntarily Revoked | 1986-06-04 |
| 2023-04-01 | 002 | Intron A | 351(a) | Disc | Voluntarily Revoked | 1986-06-04 |
| 2023-04-01 | 003 | Intron A | 351(a) | Disc | Voluntarily Revoked | 1986-06-04 |
| 2023-04-01 | 004 | Intron A | 351(a) | Disc | Voluntarily Revoked | 1986-06-04 |
| 2023-04-01 | 005 | Intron A | 351(a) | Disc | Voluntarily Revoked | |
| 2023-04-01 | 006 | Intron A | 351(a) | Disc | Voluntarily Revoked | |
| 2023-04-01 | 007 | Intron A | 351(a) | Disc | Voluntarily Revoked | |
| 2023-04-01 | 008 | Intron A | 351(a) | Disc | Voluntarily Revoked | |
| 2023-04-01 | 009 | Intron A | 351(a) | Disc | Voluntarily Revoked | |
| 2023-04-01 | 010 | Intron A | 351(a) | Disc | Voluntarily Revoked | |
| 2023-04-01 | 011 | Intron A | 351(a) | Disc | Voluntarily Revoked | |
| 2023-04-01 | 012 | Intron A | 351(a) | Disc | Voluntarily Revoked | |
| 2023-04-01 | 013 | Intron A | 351(a) | Disc | Voluntarily Revoked | |
| 2023-04-01 | 014 | Intron A | 351(a) | Disc | Voluntarily Revoked | |
| 2022-11-01 | 003 | Intron A | 351(a) | Disc | Licensed | 1986-06-04 |
| 2022-11-01 | 005 | Intron A | 351(a) | Disc | Licensed | |
| 2022-11-01 | 006 | Intron A | 351(a) | Disc | Licensed | |
| 2022-11-01 | 010 | Intron A | 351(a) | Disc | Licensed | |
| 2022-11-01 | 011 | Intron A | 351(a) | Disc | Licensed | |
| 2022-03-01 | 001 | Intron A | 351(a) | Disc | Licensed | 1986-06-04 |
| 2022-03-01 | 002 | Intron A | 351(a) | Disc | Licensed | 1986-06-04 |
| 2022-03-01 | 004 | Intron A | 351(a) | Disc | Licensed | 1986-06-04 |
| 2022-03-01 | 006 | Intron A | 351(a) | Rx | Licensed | |
| 2022-03-01 | 007 | Intron A | 351(a) | Disc | Licensed | |
| 2022-03-01 | 008 | Intron A | 351(a) | Disc | Licensed | |
| 2022-03-01 | 009 | Intron A | 351(a) | Disc | Licensed | |
| 2022-03-01 | 010 | Intron A | 351(a) | Rx | Licensed | |
| 2022-03-01 | 011 | Intron A | 351(a) | Rx | Licensed | |
| 2022-03-01 | 012 | Intron A | 351(a) | Disc | Licensed | |
| 2022-03-01 | 013 | Intron A | 351(a) | Disc | Licensed | |
| 2022-03-01 | 014 | Intron A | 351(a) | Disc | Licensed | |
| 2020-05-01 | 001 | Intron A | 351(a) | Rx | Licensed | 1986-06-04 |
| 2020-05-01 | 002 | Intron A | 351(a) | Rx | Licensed | 1986-06-04 |
| 2020-05-01 | 003 | Intron A | 351(a) | Rx | Licensed | 1986-06-04 |
| 2020-05-01 | 004 | Intron A | 351(a) | Rx | Licensed | 1986-06-04 |
| 2020-05-01 | 005 | Intron A | 351(a) | Rx | Licensed | |