APPLICATION
ANDA064160
TYPE
ANDA
ORIGINAL APPROVAL
2000-01-28
LATEST ACTION
2025-08-22
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription
Products
CLINDAMYCIN PHOSPHATEPrescription
CLINDAMYCIN PHOSPHATE EQ 1% BASE · GEL · TOPICAL
Approval history
2025-08-22Labeling · Supplement 26 · standardAP
2025-08-22Labeling · Supplement 18 · standardAP
2025-08-22Labeling · Supplement 24 · standardAP
2025-08-22Labeling · Supplement 20 · standardAP
2025-08-22Labeling · Supplement 15 · standardAP
2005-06-02Labeling · Supplement 8AP
2004-06-16Labeling · Supplement 6AP
2003-03-31Labeling · Supplement 5AP
2002-12-16Labeling · Supplement 2AP
2001-07-27Manufacturing (CMC) · 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.
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