Orange Book product · Generic (ANDA)
BACLOFEN
BACLOFEN
At a glance
Mar 06, 2018
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 06, 2018
8 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
BACLOFEN
Strength
1MG/ML
Dosage form
INJECTABLE
Route
INTRATHECAL
TE code
AP
Application
ANDA 209594
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BACLOFEN
- 2022FLEQSUVYBrand (NDA)
NDA 215602 · AZURITY
- 2021LYVISPAHBrand (NDA)
NDA 215422 · STRIDES PHARMA INTL
- 2019OZOBAXBrand (NDA)
NDA 208193 · METACEL PHARMS LLC
- 2010GABLOFENBrand (NDA)
NDA 022462 · PIRAMAL CRITICAL
- 2003KEMSTROBrand (NDA)
NDA 021589 · UCB INC
- 1996LIORESALBrand (NDA)
NDA 020075 · AMNEAL
- —LIORESALBrand (NDA)
NDA 017851 · NOVARTIS
- 2025BACLOFENGeneric (ANDA)
ANDA 214099 · AUROBINDO PHARMA LTD
- 2025BACLOFENGeneric (ANDA)
ANDA 090334 · SOMERSET THERAPS LLC
- 2024BACLOFENGeneric (ANDA)
ANDA 214445 · RUBICON RESEARCH
- 2024BACLOFENGeneric (ANDA)
ANDA 217788 · RISING
- 2023BACLOFENGeneric (ANDA)
ANDA 217687 · MICRO 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.
