General MedicationsORALStandard
BACLOFEN
BACLOFEN
Standard Dose
15MG
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 211659 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient BACLOFEN Form and strength TABLET;ORAL - 15MG Sponsor ZYDUS LIFESCIENCES Submission history Latest submission status date: 2018-11-23 00:00:00.
Structured Monograph
Clinical summary
Approval overview BACLOFEN is listed in Drugs@FDA under application 211659 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BACLOFEN Form and strength TABLET;ORAL - 15MG Sponsor ZYDUS LIFESCIENCES Submission history Latest submission status date: 2018-11-23 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.