General MedicationsTABLET, EXTENDED RELEASEGeneric

GABAPENTIN ENACARBIL

Standard Dose

600MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: None (Tentative Approval)

Summary

Approval overview GABAPENTIN ENACARBIL is listed in Drugs@FDA under application 220420 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient GABAPENTIN ENACARBIL Form and strength TABLET, EXTENDED RELEASE - 600MG Sponsor ANNORA PHARMA PRIVATE LIMITED Submission history Latest submission status date: 2026-03-20 00:00:00.

Structured Monograph

Clinical summary

Approval overview GABAPENTIN ENACARBIL is listed in Drugs@FDA under application 220420 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient GABAPENTIN ENACARBIL Form and strength TABLET, EXTENDED RELEASE - 600MG Sponsor ANNORA PHARMA PRIVATE LIMITED Submission history Latest submission status date: 2026-03-20 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: None (Tentative Approval)
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.