General MedicationsORALGeneric

CARDENE SR

NICARDIPINE HYDROCHLORIDE

Standard Dose

45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview CARDENE SR is listed in Drugs@FDA under application 020005 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient NICARDIPINE HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor CHIESI Submission history Latest submission status date: 2016-08-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview CARDENE SR is listed in Drugs@FDA under application 020005 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient NICARDIPINE HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor CHIESI Submission history Latest submission status date: 2016-08-29 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.