Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076597
Company: BARR
Company: BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MODAFINIL | MODAFINIL | 100MG | Tablet; Oral | None (Tentative Approval) | None | No | No |
MODAFINIL | MODAFINIL | 200MG | Tablet; 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 |
---|---|---|---|---|---|---|---|
01/07/2004 | ORIG-1 | Tentative Approval |
Label is not available on this site. |