Application 219800
- Type
- ANDA
- Sponsor
- GRANULES PHARMACEUTICALS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMPHETAMINE | AMPHETAMINE | TABLET, ORALLY DISINTEGRATING;ORAL | 3.1MG | No | No |
| 002 | AMPHETAMINE | AMPHETAMINE | TABLET, ORALLY DISINTEGRATING;ORAL | 6.3MG | No | No |
| 003 | AMPHETAMINE | AMPHETAMINE | TABLET, ORALLY DISINTEGRATING;ORAL | 9.4MG | No | No |
| 004 | AMPHETAMINE | AMPHETAMINE | TABLET, ORALLY DISINTEGRATING;ORAL | 12.5MG | No | No |
| 005 | AMPHETAMINE | AMPHETAMINE | TABLET, ORALLY DISINTEGRATING;ORAL | 15.7MG | No | No |
| 006 | AMPHETAMINE | AMPHETAMINE | TABLET, ORALLY DISINTEGRATING;ORAL | 18.8MG | 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 |
|---|---|---|---|---|---|---|
| Adzenys XR-ODT | AMPHETAMINE | Neos Therapeutics Brands, LLC | c1179269-00b5-48ea-972d-31e614e99b7e | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | AMPHETAMINE |
| Dyanavel XR | AMPHETAMINE | NextWave Pharmaceuticals, Inc | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 2026-02-24 | Boxed warning, Warnings, Adverse reactions | AMPHETAMINE |
| Amphetamine Sulfate | AMPHETAMINE | Amneal Pharmaceuticals NY LLC | 53d40847-e0d3-48ec-81a7-ec5478553565 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | AMPHETAMINE |
| Amphetamine | AMPHETAMINE | Teva Pharmaceuticals, Inc. | 243e88e7-6621-47e9-8d5c-3f79bcb088bb | 2025-09-01 | Boxed warning, Warnings, Adverse reactions | Amphetamine AMPHETAMINE |