Application 103362
- Type
- BLA
- Sponsor
- BERLEX LABS
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 103362 | Leukine | sargramostim | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEUKINE | SARGRAMOSTIM | VIAL | 250UG/ML | No | No |
| 002 | LEUKINE | SARGRAMOSTIM | VIAL | 500UG/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 |
|---|---|---|---|---|---|---|
| Leukine | SARGRAMOSTIM | Partner Therapeutics, Inc. | bb9a3820-f31a-4dd9-bef4-97094c01a398 | 2024-12-06 | Warnings, Adverse reactions | BLA103362 71837-5843 |
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 |
|---|---|---|---|---|---|
| 0024-5843 | Leukine | SARGRAMOSTIM | sanofi-aventis U.S. LLC | BLA | Current |
| 0024-5844 | Leukine | SARGRAMOSTIM | sanofi-aventis U.S. LLC | BLA | Current |
| 71837-5843 | Leukine | SARGRAMOSTIM | Partner Therapeutics, Inc | BLA | Current |
| 71837-5843 | Leukine | SARGRAMOSTIM | Partner Therapeutics, Inc | BLA | Current |
| 71837-5843 | Leukine | SARGRAMOSTIM | Partner Therapeutics, Inc | BLA | Current |
| 71837-5843 | Leukine | SARGRAMOSTIM | Partner Therapeutics, Inc | BLA | Current |
| 71837-5843 | Leukine | SARGRAMOSTIM | Partner Therapeutics, Inc | BLA | Current |
| 71837-5843 | Leukine | SARGRAMOSTIM | Partner Therapeutics, Inc | BLA | Current |
| 71837-5844 | Leukine | SARGRAMOSTIM | Partner Therapeutics, Inc | BLA | Current |