Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019001
Company: MEDPOINTE PHARM HLC
Company: MEDPOINTE PHARM HLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BEPADIN | BEPRIDIL HYDROCHLORIDE | 200MG | TABLET;ORAL | Discontinued | None | No | No |
BEPADIN | BEPRIDIL HYDROCHLORIDE | 300MG | TABLET;ORAL | Discontinued | None | No | No |
BEPADIN | BEPRIDIL HYDROCHLORIDE | 400MG | 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 |
---|---|---|---|---|---|---|---|
12/28/1990 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |