Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 006412
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DECAPRYN | DOXYLAMINE SUCCINATE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
DECAPRYN | DOXYLAMINE SUCCINATE | 12.5MG | TABLET;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 |
---|---|---|---|---|---|---|---|
04/07/1948 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |