Application 020032
- Type
- BLA
- Sponsor
- ABBVIE
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 020032 | Survanta | beractant | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SURVANTA | BERACTANT | SUSPENSION;INTRATRACHEAL | 25MG/ML | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Survanta | BERACTANT | AbbVie Inc. | 7ef9e3a5-fc39-4ae1-0dad-6b47a1684635 | 2020-10-15 | Warnings, Adverse reactions | BLA020032 0074-1040 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0074-1040 | Survanta | Beractant | AbbVie Inc. | BLA | Current |
| 0074-1040 | Survanta | Beractant | AbbVie Inc. | BLA | Current |
| 0074-1040 | Survanta | Beractant | AbbVie Inc. | NDA | Current |
| 0074-1040 | Survanta | Beractant | AbbVie Inc. | BLA | Current |
| 0074-1040 | Survanta | Beractant | AbbVie Inc. | NDA | Current |
| 0074-1040 | Survanta | Beractant | AbbVie Inc. | BLA | Current |
| 0074-1040 | Survanta | Beractant | AbbVie Inc. | NDA | Current |
| 0074-1040 | Survanta | Beractant | AbbVie Inc. | BLA | Current |
| 0074-1040 | Survanta | Beractant | AbbVie Inc. | BLA | Current |