General MedicationsORALStandard

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Standard Dose

10MG; 40MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE is listed in Drugs@FDA under application 078466 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE Form and strength CAPSULE; ORAL - 10MG; 40MG Sponsor LUPIN PHARMS Submission history Latest submission status date: 2020-02-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE is listed in Drugs@FDA under application 078466 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE Form and strength CAPSULE; ORAL - 10MG; 40MG Sponsor LUPIN PHARMS Submission history Latest submission status date: 2020-02-21 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.