General MedicationsTOPICALStandard

AZELAIC ACID

Standard Dose

15%

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview AZELAIC ACID is listed in Drugs@FDA under application 210549 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AZELAIC ACID Form and strength GEL;TOPICAL - 15% Sponsor SUN PHARMA CANADA Submission history Latest submission status date: 2022-10-31 00:00:00.

Structured Monograph

Clinical summary

Approval overview AZELAIC ACID is listed in Drugs@FDA under application 210549 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AZELAIC ACID Form and strength GEL;TOPICAL - 15% Sponsor SUN PHARMA CANADA Submission history Latest submission status date: 2022-10-31 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.