General MedicationsORALStandard
GABAPENTIN
GABAPENTIN
Standard Dose
600MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview GABAPENTIN is listed in Drugs@FDA under application 218491 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient GABAPENTIN Form and strength TABLET;ORAL - 600MG Sponsor SCIEGEN PHARMS Submission history Latest submission status date: 2025-09-19 00:00:00.
Structured Monograph
Clinical summary
Approval overview GABAPENTIN is listed in Drugs@FDA under application 218491 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GABAPENTIN Form and strength TABLET;ORAL - 600MG Sponsor SCIEGEN PHARMS Submission history Latest submission status date: 2025-09-19 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.