General MedicationsORALStandard
PREGABALIN
PREGABALIN
Standard Dose
50MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview PREGABALIN is listed in Drugs@FDA under application 218529 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient PREGABALIN Form and strength CAPSULE;ORAL - 50MG Sponsor FOURRTS LABS Submission history Latest submission status date: 2026-02-24 00:00:00.
Structured Monograph
Clinical summary
Approval overview PREGABALIN is listed in Drugs@FDA under application 218529 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PREGABALIN Form and strength CAPSULE;ORAL - 50MG Sponsor FOURRTS LABS Submission history Latest submission status date: 2026-02-24 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.