Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010911
Company: STUART PHARMS
Company: STUART PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUCLADIN-S | BUCLIZINE HYDROCHLORIDE | 50MG | 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 |
---|---|---|---|---|---|---|---|
04/08/1957 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |