General MedicationsORALGeneric

MEMANTINE HYDROCHLORIDE

Standard Dose

7MG

Max Dose

Refer to approved labeling

Primary Use

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

Summary

Approval overview MEMANTINE HYDROCHLORIDE is listed in Drugs@FDA under application 214731 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient MEMANTINE HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 7MG Sponsor NOVAST LABS LTD Submission history Latest submission status date: 2022-08-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview MEMANTINE HYDROCHLORIDE is listed in Drugs@FDA under application 214731 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient MEMANTINE HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 7MG Sponsor NOVAST LABS LTD Submission history Latest submission status date: 2022-08-11 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

No interaction notes stored yet.