Application 220420
- Type
- ANDA
- Sponsor
- ANNORA PHARMA PRIVATE LIMITED
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | GABAPENTIN ENACARBIL | GABAPENTIN ENACARBIL | TABLET, EXTENDED RELEASE | 600MG | 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 |
|---|---|---|---|---|---|---|
| Horizant | GABAPENTIN ENACARBIL | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 4c486fc7-c8c4-4c6c-b30c-366dabaeaadd | 2025-04-28 | Warnings, Adverse reactions | GABAPENTIN ENACARBIL |