Application 206418
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | TAPENTADOL | TAPENTADOL | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 003 | TAPENTADOL | TAPENTADOL | TABLET, EXTENDED RELEASE;ORAL | 150MG | No | No |
| 004 | TAPENTADOL | TAPENTADOL | TABLET, EXTENDED RELEASE;ORAL | 200MG | No | No |
| 005 | TAPENTADOL | TAPENTADOL | TABLET, EXTENDED RELEASE;ORAL | 250MG | No | No |
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 |
|---|---|---|---|---|---|---|
| TAPENTADOL | TAPENTADOL HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 863f3fd3-1e8d-41b0-855f-8f9a29237cda | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | TAPENTADOL |
| TAPENTADOL | TAPENTADOL HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 38de863e-56ff-4c43-9ab8-9b3e1ba82858 | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | TAPENTADOL |