Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206803
Company: RISING
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SELEGILINE HYDROCHLORIDE | SELEGILINE HYDROCHLORIDE | 5MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
04/02/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
SELEGILINE HYDROCHLORIDE
CAPSULE;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 | CAPSULE;ORAL | Prescription | No | AB | 075321 | APOTEX |
SELEGILINE HYDROCHLORIDE | SELEGILINE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 075352 | NOVITIUM PHARMA |
SELEGILINE HYDROCHLORIDE | SELEGILINE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 206803 | RISING |