Application 216108
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FENFLURAMINE | FENFLURAMINE | SOLUTION;ORAL | 2.2MG/ML | No | No |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fintepla | FENFLURAMINE | UCB, Inc. | e88f360e-33ad-4cd6-b2de-5ef885857c5d | 2025-10-27 | Boxed warning, Warnings, Adverse reactions | FENFLURAMINE |