General MedicationsORALStandard
LAMOTRIGINE
LAMOTRIGINE
Standard Dose
2MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview LAMOTRIGINE is listed in Drugs@FDA under application 078009 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient LAMOTRIGINE Form and strength TABLET, CHEWABLE; ORAL - 2MG Sponsor ZYDUS PHARMS USA INC Submission history Latest submission status date: 2025-09-29 00:00:00.
Structured Monograph
Clinical summary
Approval overview LAMOTRIGINE is listed in Drugs@FDA under application 078009 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LAMOTRIGINE Form and strength TABLET, CHEWABLE; ORAL - 2MG Sponsor ZYDUS PHARMS USA INC Submission history Latest submission status date: 2025-09-29 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.