Application 209369
- Type
- ANDA
- Sponsor
- RHODES PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | TAPENTADOL HYDROCHLORIDE | TAPENTADOL HYDROCHLORIDE | TABLET;ORAL | 75MG | No | No |
| 003 | TAPENTADOL HYDROCHLORIDE | TAPENTADOL HYDROCHLORIDE | TABLET;ORAL | 100MG | 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 Hydrochloride | TAPENTADOL HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | e0ecb809-6a55-4afe-b981-b8f174e5c344 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | Tapentadol Hydrochloride TAPENTADOL HYDROCHLORIDE |
| TAPENTADOL | TAPENTADOL HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 863f3fd3-1e8d-41b0-855f-8f9a29237cda | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | TAPENTADOL HYDROCHLORIDE |
| TAPENTADOL | TAPENTADOL HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 38de863e-56ff-4c43-9ab8-9b3e1ba82858 | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | TAPENTADOL HYDROCHLORIDE |
| Tapentadol Hydrochloride | TAPENTADOL HYDROCHLORIDE | EPIC PHARMA LLC | fecd2104-5bf3-47ed-a6f0-5c6ebb0a17b4 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | Tapentadol Hydrochloride TAPENTADOL HYDROCHLORIDE |
| Nucynta ER | TAPENTADOL HYDROCHLORIDE | Collegium Pharmaceutical, Inc. | c3d04d70-0155-4147-9ce4-a3b1fad4b373 | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | TAPENTADOL HYDROCHLORIDE |
| Nucynta | TAPENTADOL HYDROCHLORIDE | Collegium Pharmaceutical, Inc. | 80938c30-9fe3-4c7d-9d9c-5476638cfb2d | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | TAPENTADOL HYDROCHLORIDE |