Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204762
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DANTROLENE SODIUM | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
06/19/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DANTROLENE SODIUM
INJECTABLE;INJECTION; 20MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DANTRIUM | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 018264 | PAR STERILE PRODUCTS |
DANTROLENE SODIUM | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204762 | HIKMA |
REVONTO | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 078378 | USWM |