APPLICATION
ANDA065242
TYPE
ANDA
ORIGINAL APPROVAL
2005-08-12
LATEST ACTION
2017-07-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CLINDAMYCIN HYDROCHLORIDEPrescription
CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE · CAPSULE · ORAL
CLINDAMYCIN HYDROCHLORIDEPrescription
CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE · CAPSULE · ORAL
Approval history
2017-07-24Labeling · Supplement 21 · standardAP
2017-03-24Labeling · Supplement 16 · standardAP
2017-03-24Labeling · Supplement 20 · standardAP
2014-12-21Labeling · Supplement 15 · standardAP
2014-08-25Labeling · Supplement 5AP
2014-08-22Labeling · Supplement 2AP
2011-12-20Labeling · Supplement 12AP
2010-12-22Labeling · Supplement 11AP
2007-06-08Labeling · Supplement 6AP
2005-08-12OriginalAP
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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