Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202802
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
| 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 |
|---|---|---|---|---|---|---|---|
| 10/30/2015 | ORIG-1 | Tentative Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202802Orig1s000TAltr.pdf |
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