Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202836
Company: SANDOZ INC
Company: SANDOZ INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
08/17/2015 | ORIG-1 | Tentative Approval |
Label is not available on this site. |