Orange Book product · Generic (ANDA)
BACLOFEN
BACLOFEN
At a glance
Dec 06, 2024
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 06, 2024
1 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
BACLOFEN
Strength
5MG/5ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
ANDA 214445
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 217788 · RISING
- 2023BACLOFENGeneric (ANDA)
ANDA 217687 · MICRO LABS
- 2023BACLOFENGeneric (ANDA)
ANDA 214114 · REGCON HOLDINGS
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.
