Application 018264
- Type
- NDA
- Sponsor
- PAR STERILE PRODUCTS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DANTRIUM | DANTROLENE SODIUM | INJECTABLE;INJECTION | 20MG/VIAL | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42023-123 | Dantrium | dantrolene sodium | Par Pharmaceutical, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 78047 | SUPPL | 2024-04-03 |
| 78038 | SUPPL | 2024-04-03 |
| 11188 | SUPPL | 2008-11-07 |
| 14962 | SUPPL | 2008-10-27 |