Orange Book product · Brand (NDA)
RYANODEX
DANTROLENE SODIUM
At a glance
Jul 22, 2014
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 22, 2014
12 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
DANTROLENE SODIUM
Strength
250MG/VIAL
Dosage form
FOR SUSPENSION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 205579
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- —DANTRIUMBrand (NDA)
NDA 017443 · PH HEALTH
- —DANTRIUMBrand (NDA)
NDA 018264 · PH HEALTH
- 2017DANTROLENE SODIUMGeneric (ANDA)
ANDA 204762 · HIKMA
- 2016DANTROLENE SODIUMGeneric (ANDA)
ANDA 205239 · EUGIA PHARMA SPECLTS
- 2007REVONTOGeneric (ANDA)
ANDA 078378 · USWM
- 2005DANTROLENE SODIUMGeneric (ANDA)
ANDA 076686 · ELITE LABS INC
- 2005DANTROLENE SODIUMGeneric (ANDA)
ANDA 076856 · IMPAX LABS
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.
