Composition
- Active ingredients
- AZELAIC ACID 15%
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- AZELAIC ACID 15% · Aerosol, foamANDA212581-001 · Tentative approval
- AZELAIC ACID 15% · GelThis page
- AZELAIC ACID 15% · GelANDA204637-001 · Prescription
- AZELAIC ACID 15% · GelANDA208724-001 · Prescription
- AZELAIC ACID 15% · GelANDA208011-001 · Prescription
- AZELAIC ACID 15% · Aerosol, foamANDA210928-001 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA210549.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Azelaic Acid
- Route
- Topical
- Dosage form
- Gel
- Applicant
- Sun Pharma Canada
- Status
- Prescription
- FDA approval
- 23 Aug 2019
- Application
- ANDA210549-001