APPLICATION
ANDA064159
TYPE
ANDA
ORIGINAL APPROVAL
1997-06-05
LATEST ACTION
2025-08-22
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
CLINDAMYCIN PHOSPHATEPrescription
CLINDAMYCIN PHOSPHATE EQ 1% BASE · SOLUTION · TOPICAL
Approval history
2025-08-22Labeling · Supplement 17 · standardAP
2025-08-22Labeling · Supplement 13 · standardAP
2025-08-22Labeling · Supplement 16 · standardAP
2025-08-22Labeling · Supplement 20 · standardAP
2025-08-22Labeling · Supplement 19 · standardAP
2005-06-02Labeling · Supplement 4AP
2004-06-16Labeling · Supplement 2AP
2001-02-26Manufacturing (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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