Application 204972
- Type
- ANDA
- Sponsor
- ACTAVIS ELIZABETH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TAPENTADOL | TAPENTADOL | TABLET, EXTENDED RELEASE;ORAL | 50MG | No | No |
| 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#
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 |
|---|---|---|---|---|---|---|
| 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 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 48652 | ORIG | 2017-06-06 |