Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019456
Company: LEO PHARM
Company: LEO PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PINDAC | PINACIDIL | 12.5MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
PINDAC | PINACIDIL | 25MG | CAPSULE, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
12/28/1989 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |