Application Nr Approved Date Route Status External Links
ANDA078162 None Topical None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Halobetasol Propionate Cream, 0.05% Is A Super-High Potency Corticosteroid Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid-Responsive Dermatoses. Treatment Beyond Two Consecutive Weeks Is Not Recommended, And The Total Dosage Should Not Exceed 50 G/week Because Of The Potential For The Drug To Suppress The Hypothalamic-Pituitary-Adrenal (hpa) Axis. Use In Children Under 12 Years Of Age Is Not Recommended. As With Other Highly Active Corticosteroids, Therapy Should Be Discontinued When Control Has Been Achieved. If No Improvement Is Seen Within 2 Weeks, Reassessment Of The Diagnosis May Be Necessary.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Halobetasol Propionate

Comments