Application 050443
- Type
- NDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BLENOXANE | BLEOMYCIN SULFATE | INJECTABLE;INJECTION | EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | BLENOXANE | BLEOMYCIN SULFATE | INJECTABLE;INJECTION | EQ 30 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050443-001 | BLENOXANE | BLEOMYCIN SULFATE | EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N050443-002 | BLENOXANE | BLEOMYCIN SULFATE | EQ 30 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-09-07 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N050443-001 | BLENOXANE | EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N050443-002 | BLENOXANE | EQ 30 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-09-07 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N050443-001 | BLENOXANE | EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N050443-002 | BLENOXANE | EQ 30 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-09-07 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050443-001 | BLENOXANE | EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050443-002 | BLENOXANE | EQ 30 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-09-07 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N050443-001 | BLENOXANE | EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N050443-002 | BLENOXANE | EQ 30 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-09-07 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Bleomycin | BLEOMYCIN SULFATE | Meitheal Pharmaceuticals Inc. | 640602f9-a7df-46f0-a9b1-19c471008bee | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | BLEOMYCIN SULFATE |
| Bleomycin | BLEOMYCIN SULFATE | Fresenius Kabi USA, LLC | b5806c40-12ce-48e3-8abd-9f8997ef4428 | 2024-10-10 | Boxed warning, Warnings, Adverse reactions | BLEOMYCIN SULFATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.