Skip to contentApplication 078378
- Type
- ANDA
- Sponsor
- US WORLDMEDS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | REVONTO | DANTROLENE SODIUM | INJECTABLE;INJECTION | 20MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 27505-003 | Revonto | dantrolene sodium | US WorldMeds, LLC | ANDA | Current |
| 27505-003 | Revonto | dantrolene sodium | US WorldMeds, LLC | ANDA | Current |
| 27505-003 | Revonto | dantrolene sodium | US WorldMeds, LLC | ANDA | Current |
| 78670-003 | Revonto | dantrolene sodium | USWM, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9151 | ORIG | 2007-07-27 |