Orange Book product · Generic (ANDA)
METAXALONE
METAXALONE
At a glance
Oct 21, 2020
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 21, 2020
5 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
METAXALONE
Strength
800MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 213836
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of METAXALONE
- 2015METAXALONEBrand (NDA)
NDA 022503 · PRIMUS PHARMS
- —SKELAXINBrand (NDA)
NDA 013217 · KING PHARMS
- 2020METAXALONEGeneric (ANDA)
ANDA 207466 · SCIEGEN PHARMS
- 2018METAXALONEGeneric (ANDA)
ANDA 208774 · RISING
- 2017METAXALONEGeneric (ANDA)
ANDA 203695 · ACTAVIS LABS FL INC
- 2016METAXALONEGeneric (ANDA)
ANDA 204770 · LANNETT CO INC
- 2015METAXALONEGeneric (ANDA)
ANDA 040486 · MOUNTAIN
- 2013METAXALONEGeneric (ANDA)
ANDA 203399 · AMNEAL PHARMS
- 2010METAXALONEGeneric (ANDA)
ANDA 040445 · SANDOZ
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.
