Orange Book product · Generic (ANDA)
DANTROLENE SODIUM
DANTROLENE SODIUM
At a glance
Feb 18, 2016
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 18, 2016
10 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
DANTROLENE SODIUM
Strength
20MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 205239
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DANTROLENE SODIUM
- 2014RYANODEXBrand (NDA)
NDA 205579 · EAGLE PHARMS
- —DANTRIUMBrand (NDA)
NDA 017443 · PH HEALTH
- —DANTRIUMBrand (NDA)
NDA 018264 · PH HEALTH
- 2017DANTROLENE SODIUMGeneric (ANDA)
ANDA 204762 · HIKMA
- 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.
