APPLICATION
ANDA065442
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-26
LATEST ACTION
2023-05-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CLINDAMYCIN HYDROCHLORIDEPrescription
CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE · CAPSULE · ORAL
CLINDAMYCIN HYDROCHLORIDEPrescription
CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE · CAPSULE · ORAL
Approval history
2023-05-09Labeling · Supplement 19 · standardAP
2019-08-19Labeling · Supplement 12 · standardAP
2019-08-19Labeling · Supplement 9 · standardAP
2019-08-19Labeling · Supplement 15 · standardAP
2019-08-19Labeling · Supplement 11 · standardAP
2019-08-19Labeling · Supplement 8 · standardAP
2015-01-16Labeling · Supplement 7 · standardAP
2011-12-27Labeling · Supplement 3AP
2010-05-20Labeling · Supplement 1AP
2009-08-26OriginalAP
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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