Application 209877
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PERAMPANEL | PERAMPANEL | TABLET;ORAL | 2MG | No | No |
| 002 | PERAMPANEL | PERAMPANEL | TABLET;ORAL | 4MG | No | No |
| 003 | PERAMPANEL | PERAMPANEL | TABLET;ORAL | 6MG | No | No |
| 004 | PERAMPANEL | PERAMPANEL | TABLET;ORAL | 8MG | No | No |
| 005 | PERAMPANEL | PERAMPANEL | TABLET;ORAL | 10MG | No | No |
| 006 | PERAMPANEL | PERAMPANEL | TABLET;ORAL | 12MG | 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 |
|---|---|---|---|---|---|---|
| PERAMPANEL | PERAMPANEL | Sun Pharmaceutical Industries, Inc. | 3c72a5f7-bb22-4c48-942a-543ca84ed5a9 | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | PERAMPANEL PERAMPANEL |
| Perampanel | PERAMPANEL | Sun Pharmaceutical Industries, Inc. | 1b0458ea-e718-4d48-ae55-ad9b4d863810 | 2025-12-19 | Boxed warning, Warnings, Adverse reactions | Perampanel PERAMPANEL |
| Perampanel | PERAMPANEL | Novadoz Pharmaceuticals LLC | 695c8c73-39cb-4927-bdf6-72d16e4aa9bb | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | Perampanel PERAMPANEL |
| Perampanel | PERAMPANEL | Teva Pharmaceuticals, Inc. | bc8f7cf2-c19c-4235-859f-9ff1dd21908e | 2024-09-01 | Boxed warning, Warnings, Adverse reactions | Perampanel PERAMPANEL |
| Fycompa | PERAMPANEL | Catalyst Pharmaceuticals, Inc. | ec812ea3-de3a-4271-957c-db8f692d1ae3 | 2024-01-05 | Boxed warning, Warnings, Adverse reactions | PERAMPANEL |
| Fycompa | PERAMPANEL | Eisai Inc. | 71cf3309-e182-473c-8b0b-280cabd0e122 | 2022-12-28 | Boxed warning, Warnings, Adverse reactions | PERAMPANEL |
| PERAMPANEL | PERAMPANEL | Novadoz Pharmaceuticals LLC | 4d8be129-f3cb-49ad-ae5a-a74a50dff689 | 2022-11-26 | Boxed warning, Warnings, Adverse reactions | PERAMPANEL PERAMPANEL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 52541 | ORIG | 2018-02-09 |