General MedicationsORALStandard

DICLOFENAC SODIUM

Standard Dose

100MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview DICLOFENAC SODIUM is listed in Drugs@FDA under application 216275 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DICLOFENAC SODIUM Form and strength TABLET, EXTENDED RELEASE;ORAL - 100MG Sponsor INGENUS PHARMS LLC Submission history Latest submission status date: 2024-11-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview DICLOFENAC SODIUM is listed in Drugs@FDA under application 216275 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DICLOFENAC SODIUM Form and strength TABLET, EXTENDED RELEASE;ORAL - 100MG Sponsor INGENUS PHARMS LLC Submission history Latest submission status date: 2024-11-21 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.