Orange Book product · Brand (NDA)
DANTRIUM
DANTROLENE SODIUM
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
DANTROLENE SODIUM
Strength
25MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 017443
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2014RYANODEXBrand (NDA)
NDA 205579 · EAGLE PHARMS
- —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.
