APPLICATION
ANDA083213
TYPE
ANDA
ORIGINAL APPROVAL
1973-11-13
LATEST ACTION
1973-11-13
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued
Products
PRAMOSONEDiscontinued
HYDROCORTISONE ACETATE 0.5%, PRAMOXINE HYDROCHLORIDE 1% · LOTION · TOPICAL
Approval history
1973-11-13OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.