Infasurf Purple Book BLA 020521
- BLA number
- 020521
- Proprietary names
- Infasurf
- Proper names
- calfactant
- Applicant
- ONY Biotech 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 | Infasurf | calfactant | 351(a) | 210MG/6ML (35MG/ML) | Suspension | Intratracheal | Single-Dose Vial | Rx | Licensed | 1998-07-01 | |
| 002 | Infasurf | calfactant | 351(a) | 105MG/3ML (35MG/ML) | Suspension | Intratracheal | Single-Dose Vial | Rx | Licensed | 2002-12-12 | |
| 003 | Infasurf | calfactant | 351(a) | 420MG/12ML (35MG/ML) | Suspension | Intratracheal | Single-Dose Vial | Disc | Licensed | | |
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 |
|---|
| 2020-09-01 | U | 001 | Infasurf | 351(a) | Rx | ONY Biotech Inc. |
| 2020-09-01 | U | 002 | Infasurf | 351(a) | Rx | ONY Biotech Inc. |
| 2020-05-01 | R | 001 | Infasurf | 351(a) | Rx | ONY Biotech Inc. |
| 2020-05-01 | R | 002 | Infasurf | 351(a) | Rx | ONY Biotech Inc. |
| 2020-05-01 | R | 003 | Infasurf | 351(a) | Disc | ONY Biotech Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-08-01 | 001 | Infasurf | 351(a) | Rx | Licensed | 1998-07-01 |
| 2020-08-01 | 002 | Infasurf | 351(a) | Rx | Licensed | 2002-12-12 |
| 2020-05-01 | 001 | Infasurf | 351(a) | Rx | Licensed | 2002-12-12 |
| 2020-05-01 | 002 | Infasurf | 351(a) | Rx | Licensed | 1998-07-01 |
| 2020-05-01 | 003 | Infasurf | 351(a) | Disc | Licensed | |