Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017443
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DANTRIUM | DANTROLENE SODIUM | 25MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| DANTRIUM | DANTROLENE SODIUM | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| DANTRIUM | DANTROLENE SODIUM | 50MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/17/2012 | SUPPL-49 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf | |
| 07/17/2012 | SUPPL-48 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf | |
| 07/17/2012 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf | |
| 07/17/2012 | SUPPL-43 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf |