Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074672
Company: I3 PHARMS
Company: I3 PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SELEGILINE HYDROCHLORIDE | SELEGILINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
04/01/1997 | ORIG-1 | Approval |
Label is not available on this site. |
SELEGILINE HYDROCHLORIDE
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SELEGILINE HYDROCHLORIDE | SELEGILINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 074871 | APOTEX INC |
SELEGILINE HYDROCHLORIDE | SELEGILINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 074672 | I3 PHARMS |