Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsTOPICALGeneric

AZELAIC ACID

AZELAIC ACID

Standard Dose
15%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview AZELAIC ACID is listed in Drugs@FDA under application 212581 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient AZELAIC ACID Form and strength AEROSOL, FOAM;TOPICAL - 15% Sponsor TARO PHARM INDS LTD Submission history Latest submission status date: 2021-04-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview AZELAIC ACID is listed in Drugs@FDA under application 212581 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient AZELAIC ACID Form and strength AEROSOL, FOAM;TOPICAL - 15% Sponsor TARO PHARM INDS LTD Submission history Latest submission status date: 2021-04-19 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: None (Tentative Approval)
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.