azelaic acid
azelaic acid is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand names including azelaic acid, Azelaic Acid Gel, AZELEX. Available dosage forms: gel, cream, aerosol, foam.
Drug Details
- Generic Name
- azelaic acid
- Brand Names
- azelaic acid, Azelaic Acid Gel, AZELEX, FINACEA FOAM
- Application Number
- ANDA208011
- Sponsor
- Actavis Pharma, Inc.
- NDC Codes
- 5
- Dosage Forms
- GEL, CREAM, AEROSOL, FOAM
- Routes
- TOPICAL, CUTANEOUS
- Active Ingredients
- AZELAIC ACID
Indications and Usage
1 INDICATIONS AND USAGE Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. ( 1 ) Limitations of Use Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. ( 1 ) Limitations of Use Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.