Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208937
Company: NOVAST LABS
Company: NOVAST LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOLCAPONE | TOLCAPONE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/07/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TOLCAPONE
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TASMAR | TOLCAPONE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 020697 | BAUSCH |
| TOLCAPONE | TOLCAPONE | 100MG | TABLET;ORAL | Prescription | No | AB | 208937 | NOVAST LABS |