Application 213613
- Type
- ANDA
- Sponsor
- ASCEND LABORATORIES, LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ELUXADOLINE | ELUXADOLINE | TABLET; ORAL | 75MG | No | No |
| 002 | ELUXADOLINE | ELUXADOLINE | 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 |
|---|---|---|---|---|---|---|
| Viberzi | ELUXADOLINE | Allergan, Inc. | 7821bd40-4c84-4984-951b-6436ae20421a | 2024-07-16 | Warnings, Adverse reactions | ELUXADOLINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69864 | ORIG | 2022-01-12 |