Application 211044
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | RIOCIGUAT | RIOCIGUAT | TABLET;ORAL | 1MG | No | No |
| 003 | RIOCIGUAT | RIOCIGUAT | TABLET;ORAL | 1.5MG | No | No |
| 004 | RIOCIGUAT | RIOCIGUAT | TABLET;ORAL | 2MG | No | No |
| 005 | RIOCIGUAT | RIOCIGUAT | TABLET;ORAL | 2.5MG | 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 |
|---|---|---|---|---|---|---|
| Adempas | RIOCIGUAT | Bayer HealthCare Pharmaceuticals Inc. | 7b57509a-3d5d-41d4-8fed-1471e26372a3 | 2026-08-13 | Boxed warning, Warnings, Adverse reactions | RIOCIGUAT |