General MedicationsORALStandard

ALENDRONATE SODIUM

Standard Dose

EQ 70MG BASE/75ML

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview ALENDRONATE SODIUM is listed in Drugs@FDA under application 214512 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ALENDRONATE SODIUM Form and strength SOLUTION;ORAL - EQ 70MG BASE/75ML Sponsor NOVITIUM PHARMA Submission history Latest submission status date: 2026-02-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview ALENDRONATE SODIUM is listed in Drugs@FDA under application 214512 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ALENDRONATE SODIUM Form and strength SOLUTION;ORAL - EQ 70MG BASE/75ML Sponsor NOVITIUM PHARMA Submission history Latest submission status date: 2026-02-03 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.