General MedicationsORALStandard
BACLOFEN
BACLOFEN
Standard Dose
10MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: UNKNOWN Marketing status: Prescription
Summary
Approval overview BACLOFEN is listed in Drugs@FDA under application 217788 (ANDA).
Review priority: UNKNOWN Marketing status: Prescription Active ingredient BACLOFEN Form and strength TABLET;ORAL - 10MG Sponsor RISING Submission history Latest submission status date: 2024-10-24 00:00:00.
Structured Monograph
Clinical summary
Approval overview BACLOFEN is listed in Drugs@FDA under application 217788 (ANDA). Review priority: UNKNOWN Marketing status: Prescription Active ingredient BACLOFEN Form and strength TABLET;ORAL - 10MG Sponsor RISING Submission history Latest submission status date: 2024-10-24 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: UNKNOWN
Interaction Notes
- No interaction notes stored yet.