General MedicationsORALGeneric
LYVISPAH
BACLOFEN
Standard Dose
5MG/PACKET
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary
Approval overview LYVISPAH is listed in Drugs@FDA under application 215422 (NDA).
Review priority: STANDARD Marketing status: Discontinued Active ingredient BACLOFEN Form and strength GRANULES;ORAL - 5MG/PACKET Sponsor STRIDES PHARMA INTL Submission history Latest submission status date: 2021-11-22 00:00:00.
Structured Monograph
Clinical summary
Approval overview LYVISPAH is listed in Drugs@FDA under application 215422 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient BACLOFEN Form and strength GRANULES;ORAL - 5MG/PACKET Sponsor STRIDES PHARMA INTL Submission history Latest submission status date: 2021-11-22 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.