Orange Book product · Generic (ANDA)
REVONTO
DANTROLENE SODIUM
At a glance
Jul 24, 2007
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 24, 2007
19 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
DANTROLENE SODIUM
Strength
20MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 078378
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
- 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.
