Application 089395
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VINBLASTINE SULFATE | VINBLASTINE SULFATE | INJECTABLE;INJECTION | 10MG/VIAL | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A089395-001 | VINBLASTINE SULFATE | VINBLASTINE SULFATE | 10MG/VIAL | INJECTABLE / INJECTION | RS | 1987-04-09 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A089395-001 | VINBLASTINE SULFATE | 10MG/VIAL | INJECTABLE / INJECTION | RS | 1987-04-09 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Vinblastine Sulfate | VINBLASTINE SULFATE | Fresenius Kabi USA, LLC | f073b58e-56d6-4c8d-a2ce-b37719402d77 | 2025-04-15 | Boxed warning, Warnings, Adverse reactions | Vinblastine Sulfate VINBLASTINE SULFATE |