Orange Book product · Generic (ANDA)
DANTROLENE SODIUM
DANTROLENE SODIUM
At a glance
Oct 24, 2005
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 24, 2005
20 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
DANTROLENE SODIUM
Strength
25MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 076686
Product number
001
Marketing status
RX
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
- 2016DANTROLENE SODIUMGeneric (ANDA)
ANDA 205239 · EUGIA PHARMA SPECLTS
- 2007REVONTOGeneric (ANDA)
ANDA 078378 · USWM
- 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.
