Orange Book product · Brand (NDA)
KEMSTRO
BACLOFEN
At a glance
Oct 30, 2003
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 30, 2003
23 yr ago
Today
Pharmaceutical detail
Active ingredient
BACLOFEN
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
TE code
Not listed
Application
NDA 021589
Product number
001
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.
- 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
- 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
- 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.
