Dantrolene Injectable Suspension
- Brand(s)
- Ryanodex
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Eagle Pharmaceuticals, Inc. (2014-08-01)
- Oldest Current Product
- 2014-07-23
- License(s)
- NDA
- RxNORM
- INJECTABLE SUSPENSION\DANTROLENE
- FDAOB
- INTRAVENOUS\FOR SUSPENSION\DANTROLENE SODIUM
- SPL Active
- INTRAVENOUS\INJECTION, SUSPENSION\DANTROLENE SODIUM
- SPL Moiety
- INTRAVENOUS\INJECTION, SUSPENSION\DANTROLENE
product(s) by strength(s)
dantrolene sodium 50 mg/ml injectable suspension
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 423670540 | Ryanodex | NDA | Eagle Pharmaceuticals, Inc. | 2014-07-23 | DANTROLENE SODIUM | INTRAVENOUS | INJECTION, SUSPENSION | NDA205579 | 8f7b3ac0-604d-4c78-b545-5e0f8ea3d698 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA205579 | RYANODEX | EAGLE PHARMACEUTICALS INC | 2014-07-22 | p8685460, FOR USE IN THE TREATMENT OF MALIGNANT HYPERTHERMIA IN CONJUNCTION WITH APPROPRIATE SUPPORTIVE MEASURES AND FOR THE PREVENTION OF MALIGNANT HYPERTHERMIA IN PATIENTS AT HIGH RISK. p7758890, SUBSTANCE p8604072, SUBSTANCE p8110225, SUBSTANCE | ORPHAN DRUG EXCLUSIVITY [2021-07-22] | NDA205579_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA205579_001 | RX | DANTROLENE SODIUM (250MG/VIAL) | INTRAVENOUS | FOR SUSPENSION | False | 2014-07-22 | RYANODEX |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p7758890 (view patent) | 2025-07-01 | NDA205579 |
| 2 | p8110225 (view patent) | 2022-12-24 | NDA205579 |
| 3 | p8604072 (view patent) | 2022-12-24 | NDA205579 |
| 4 | p8685460 (view patent) | 2023-02-15 | NDA205579 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 8f7b3ac0-604d-4c78-b545-5e0f8ea3d698 (view SPL) | These highlights do not include all the information needed to use RYANODEX safely and effectively. See full prescribing information for RYANODEX. RYANODEX (dantrolene sodium) for injectable suspension, for intravenous use. Initial U.S. Approval: 1974 | prescription | Human Prescription | Eagle Pharmaceuticals, Inc. | MANUFACTURE | 2014-08-01 | 2 | 423670540 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII