General MedicationsORALGeneric

GABAPENTIN ENCARBIL

Standard Dose

600MG

Max Dose

Refer to approved labeling

Primary Use

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

Summary

Approval overview GABAPENTIN ENCARBIL is listed in Drugs@FDA under application 213501 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient GABAPENTIN ENCARBIL Form and strength TABLET, EXTENDED RELEASE;ORAL - 600MG Sponsor GLENMARK PHARMS LTD Submission history Latest submission status date: 2020-12-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview GABAPENTIN ENCARBIL is listed in Drugs@FDA under application 213501 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient GABAPENTIN ENCARBIL Form and strength TABLET, EXTENDED RELEASE;ORAL - 600MG Sponsor GLENMARK PHARMS LTD Submission history Latest submission status date: 2020-12-29 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

No interaction notes stored yet.