Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078378
Company: USWM
Company: USWM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
REVONTO | 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 |
---|---|---|---|---|---|---|---|
07/24/2007 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078378s000LTR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/27/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
02/16/2010 | SUPPL-6 | Labeling-Package Insert, Labeling-Proprietary Name Change, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
02/16/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
02/16/2010 | SUPPL-4 | Labeling |
Label is not available on this site. |
REVONTO
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 |