General MedicationsORALStandard

MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Standard Dose

10MG;28MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE is listed in Drugs@FDA under application 216901 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 10MG;28MG Sponsor XIAMEN LP PHARM CO Submission history Latest submission status date: 2025-07-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE is listed in Drugs@FDA under application 216901 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 10MG;28MG Sponsor XIAMEN LP PHARM CO Submission history Latest submission status date: 2025-07-15 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.