General MedicationsINTRATHECALStandard
BACLOFEN
BACLOFEN
Standard Dose
1MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview BACLOFEN is listed in Drugs@FDA under application 217324 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient BACLOFEN Form and strength INJECTABLE;INTRATHECAL - 1MG/ML Sponsor RUBICON RESEARCH Submission history Latest submission status date: 2023-02-22 00:00:00.
Structured Monograph
Clinical summary
Approval overview BACLOFEN is listed in Drugs@FDA under application 217324 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BACLOFEN Form and strength INJECTABLE;INTRATHECAL - 1MG/ML Sponsor RUBICON RESEARCH Submission history Latest submission status date: 2023-02-22 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.