General MedicationsORALStandard

SEVELAMER HYDROCHLORIDE

Standard Dose

400MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview SEVELAMER HYDROCHLORIDE is listed in Drugs@FDA under application 213145 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SEVELAMER HYDROCHLORIDE Form and strength TABLET;ORAL - 400MG Sponsor LUPIN LTD Submission history Latest submission status date: 2021-06-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview SEVELAMER HYDROCHLORIDE is listed in Drugs@FDA under application 213145 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SEVELAMER HYDROCHLORIDE Form and strength TABLET;ORAL - 400MG Sponsor LUPIN LTD Submission history Latest submission status date: 2021-06-16 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.