Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090864
Company: PAR PHARM INC
Company: PAR PHARM INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE; ORAL | None (Tentative Approval) | None | No | No |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE; ORAL | None (Tentative Approval) | 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 |
|---|---|---|---|---|---|---|---|
| 07/26/2013 | ORIG-1 | Tentative Approval |
Label is not available on this site. |