APPLICATION
ANDA065049
TYPE
ANDA
ORIGINAL APPROVAL
2000-05-25
LATEST ACTION
2020-04-03
ROUTE
TOPICAL
DOSAGE FORM
SWAB
MARKETING STATUS
Prescription
Products
CLINDAMYCIN PHOSPHATEPrescription
CLINDAMYCIN PHOSPHATE EQ 1% BASE · SWAB · TOPICAL
Approval history
2020-04-03Labeling · Supplement 16 · standardAP
2020-04-03Labeling · Supplement 23 · standardAP
2015-07-15Labeling · Supplement 13 · standardAP
2014-01-14Labeling · Supplement 11AP
2010-10-19Labeling · Supplement 10AP
2009-11-30Labeling · Supplement 9AP
2002-06-27Labeling · Supplement 5AP
2002-06-27Manufacturing (CMC) · Supplement 4AP
2001-11-21Labeling · Supplement 3AP
2001-11-21Manufacturing (CMC) · Supplement 1AP
2001-11-21Manufacturing (CMC) · Supplement 2AP
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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