Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207199
Company: PAR PHARM INC
Company: PAR PHARM INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 03/14/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |