Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080715
Company: ALRA
Company: ALRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIMENHYDRINATE | DIMENHYDRINATE | 12.5MG/4ML | LIQUID;ORAL | Discontinued | 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 |
---|---|---|---|---|---|---|---|
05/31/1972 | ORIG-1 | Approval |
Label is not available on this site. |