Orange Book product · Brand (NDA)
ROBAXIN
METHOCARBAMOL
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
METHOCARBAMOL
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 011011
Product number
004
Marketing status
DISCN
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.
- 2025ATMEKSIBrand (NDA)
NDA 219843 · ROSEMONT PHARMS
- —ROBAXINBrand (NDA)
NDA 011790 · HIKMA
- 2023METHOCARBAMOLGeneric (ANDA)
ANDA 212707 · MIKART
- 2023METHOCARBAMOLGeneric (ANDA)
ANDA 213967 · AUROBINDO PHARMA LTD
- 2022METHOCARBAMOLGeneric (ANDA)
ANDA 215065 · BAXTER HLTHCARE CORP
- 2021METHOCARBAMOLGeneric (ANDA)
ANDA 200958 · BOSTAL
- 2018METHOCARBAMOLGeneric (ANDA)
ANDA 211504 · GLAND
- 2018METHOCARBAMOLGeneric (ANDA)
ANDA 209312 · GRANULES
- 2018METHOCARBAMOLGeneric (ANDA)
ANDA 209331 · FRESENIUS KABI USA
- 2017METHOCARBAMOLGeneric (ANDA)
ANDA 206071 · NAVINTA LLC
- 2017METHOCARBAMOLGeneric (ANDA)
ANDA 207522 · SOMERSET THERAPS LLC
- 2017METHOCARBAMOLGeneric (ANDA)
ANDA 205404 · SAGENT PHARMS INC
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.
