FDA Orange Book · active-ingredient family
Dantrolene sodium
Dantrolene sodium is approved as 3 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:RYANODEX · NDA 205579
3
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, for suspension, injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RYANODEXRLD | EAGLE PHARMS | NDA 205579 | — | Jul 22, 2014 | |
| DANTRIUMRLD×3 | PH HEALTH | NDA 017443 | AB | Approved Prior to Jan 1, 1982 | |
| DANTRIUMRLD | PH HEALTH | NDA 018264 | AP | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DANTROLENE SODIUM | HIKMA | ANDA 204762 | AP | Jun 19, 2017 | |
| DANTROLENE SODIUM | EUGIA PHARMA SPECLTS | ANDA 205239 | — | Feb 18, 2016 | |
| REVONTO | USWM | ANDA 078378 | AP | Jul 24, 2007 | |
| DANTROLENE SODIUM×3 | ELITE LABS INC | ANDA 076686 | AB | Oct 24, 2005 | |
| DANTROLENE SODIUM×3 | IMPAX LABS | ANDA 076856 | AB | Mar 01, 2005 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Dantrolene sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
