Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090756
Company: MISSION PHARMACAL
Company: MISSION PHARMACAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CARBINOXAMINE MALEATE | CARBINOXAMINE MALEATE | 4MG | TABLET;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
05/27/2011 | ORIG-1 | Approval |
Label is not available on this site. |
CARBINOXAMINE MALEATE
TABLET;ORAL; 4MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARBINOXAMINE MALEATE | CARBINOXAMINE MALEATE | 4MG | TABLET;ORAL | Prescription | No | AA | 040442 | GENUS |
CARBINOXAMINE MALEATE | CARBINOXAMINE MALEATE | 4MG | TABLET;ORAL | Prescription | No | AA | 090756 | MISSION PHARMACAL |