COMVAX Purple Book BLA 103623
- BLA number
- 103623
- Proprietary names
- COMVAX
- Proper names
- Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine
- Applicant
- Merck Sharp & Dohme LLC
- Center
- CBER
- First observed release
- 2022-05-01
- 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 | COMVAX | Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine | 351(a) | 7.5UG PRP/125UG OMPC/5UG HBsAg | Injection | Intramuscular | Vial | Disc | Voluntarily Revoked | 1996-10-02 | |
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 |
|---|
| 2023-06-01 | U | 001 | COMVAX | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2023-03-01 | U | 001 | COMVAX | 351(a) | Rx | Merck Sharp & Dohme LLC |
| 2022-05-01 | N | 001 | COMVAX | 351(a) | Rx | Merck Sharp & Dohme Corp. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2023-06-01 | 001 | COMVAX | 351(a) | Disc | Voluntarily Revoked | 1996-10-02 |
| 2022-05-01 | 001 | COMVAX | 351(a) | Rx | Voluntarily Revoked | 1996-10-02 |