Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213316
Company: SLATE RUN PHARMA
Company: SLATE RUN PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TETRABENAZINE | TETRABENAZINE | 12.5MG | TABLET;ORAL | Prescription | AB | No | No |
TETRABENAZINE | TETRABENAZINE | 25MG | 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 |
---|---|---|---|---|---|---|---|
01/22/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TETRABENAZINE
TABLET;ORAL; 12.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TETRABENAZINE | TETRABENAZINE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 206093 | APOTEX |
TETRABENAZINE | TETRABENAZINE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 208826 | BIONPHARMA |
TETRABENAZINE | TETRABENAZINE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 210544 | CHARTWELL RX |
TETRABENAZINE | TETRABENAZINE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 209284 | DR REDDYS |
TETRABENAZINE | TETRABENAZINE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 204574 | HETERO LABS LTD V |
TETRABENAZINE | TETRABENAZINE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 207682 | MYLAN |
TETRABENAZINE | TETRABENAZINE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 213316 | SLATE RUN PHARMA |
XENAZINE | TETRABENAZINE | 12.5MG | TABLET;ORAL | Prescription | Yes | AB | 021894 | BAUSCH |
TABLET;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TETRABENAZINE | TETRABENAZINE | 25MG | TABLET;ORAL | Prescription | No | AB | 206686 | ACTAVIS LABS FL INC |
TETRABENAZINE | TETRABENAZINE | 25MG | TABLET;ORAL | Prescription | No | AB | 206093 | APOTEX |
TETRABENAZINE | TETRABENAZINE | 25MG | TABLET;ORAL | Prescription | No | AB | 208826 | BIONPHARMA |
TETRABENAZINE | TETRABENAZINE | 25MG | TABLET;ORAL | Prescription | No | AB | 210544 | CHARTWELL RX |
TETRABENAZINE | TETRABENAZINE | 25MG | TABLET;ORAL | Prescription | No | AB | 209284 | DR REDDYS |
TETRABENAZINE | TETRABENAZINE | 25MG | TABLET;ORAL | Prescription | No | AB | 204574 | HETERO LABS LTD V |
TETRABENAZINE | TETRABENAZINE | 25MG | TABLET;ORAL | Prescription | No | AB | 207682 | MYLAN |
TETRABENAZINE | TETRABENAZINE | 25MG | TABLET;ORAL | Prescription | No | AB | 213316 | SLATE RUN PHARMA |
XENAZINE | TETRABENAZINE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 021894 | BAUSCH |