Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 219800
Company: GRANULES PHARMACEUTICALS INC
Company: GRANULES PHARMACEUTICALS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMPHETAMINE | AMPHETAMINE | 3.1MG | TABLET, ORALLY DISINTEGRATING;ORAL | None (Tentative Approval) | None | No | No |
| AMPHETAMINE | AMPHETAMINE | 6.3MG | TABLET, ORALLY DISINTEGRATING;ORAL | None (Tentative Approval) | None | No | No |
| AMPHETAMINE | AMPHETAMINE | 9.4MG | TABLET, ORALLY DISINTEGRATING;ORAL | None (Tentative Approval) | None | No | No |
| AMPHETAMINE | AMPHETAMINE | 12.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | None (Tentative Approval) | None | No | No |
| AMPHETAMINE | AMPHETAMINE | 15.7MG | TABLET, ORALLY DISINTEGRATING;ORAL | None (Tentative Approval) | None | No | No |
| AMPHETAMINE | AMPHETAMINE | 18.8MG | TABLET, ORALLY DISINTEGRATING;ORAL | None (Tentative Approval) | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/19/2025 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |