Application 206649
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DRONEDARONE | DRONEDARONE | TABLET;ORAL | 400MG | 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 |
|---|---|---|---|---|---|---|
| Multaq | DRONEDARONE | Cardinal Health 107, LLC | 3bd4006a-8bad-4909-ac6d-b6d84390155c | 2026-01-27 | Boxed warning, Warnings, Adverse reactions | DRONEDARONE |
| Multaq | DRONEDARONE | Sanofi-Aventis U.S. LLC | 7fa41601-7fb5-4155-8e50-2ae903f0d2d6 | 2025-05-29 | Boxed warning, Warnings, Adverse reactions | DRONEDARONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 48654 | ORIG | 2017-06-06 |