APPLICATION
ANDA065067
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-31
LATEST ACTION
2025-08-22
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Prescription
Products
CLINDAMYCIN PHOSPHATEPrescription
CLINDAMYCIN PHOSPHATE EQ 1% BASE · LOTION · TOPICAL
Approval history
2025-08-22Labeling · Supplement 20 · standardAP
2025-08-22Labeling · Supplement 17 · standardAP
2025-08-22Labeling · Supplement 23 · standardAP
2025-08-22Labeling · Supplement 15 · standardAP
2025-08-22Labeling · Supplement 18 · standardAP
2005-06-02Labeling · Supplement 8AP
2004-06-16Labeling · Supplement 6AP
2003-05-13Labeling · Supplement 3AP
2002-12-16Labeling · Supplement 1AP
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.