Orange Book product · Generic (ANDA)
METAXALONE
METAXALONE
At a glance
Jun 21, 2013
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 21, 2013
13 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
METAXALONE
Strength
800MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 203399
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of METAXALONE
- 2015METAXALONEBrand (NDA)
NDA 022503 · PRIMUS PHARMS
- —SKELAXINBrand (NDA)
NDA 013217 · KING PHARMS
- 2020METAXALONEGeneric (ANDA)
ANDA 213836 · INGENUS PHARMS LLC
- 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
- 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.
