APPLICATION
ANDA065243
TYPE
ANDA
ORIGINAL APPROVAL
2005-08-12
LATEST ACTION
2025-09-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued, Prescription
Products
CLINDAMYCIN HYDROCHLORIDEDiscontinued
CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE · CAPSULE · ORAL
CLINDAMYCIN HYDROCHLORIDEDiscontinued
CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE · CAPSULE · ORAL
CLINDAMYCIN HYDROCHLORIDEPrescription
CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE · CAPSULE · ORAL
Approval history
2025-09-09Labeling · Supplement 29 · standardAP
2025-09-09Labeling · Supplement 28 · standardAP
2025-09-09Labeling · Supplement 24 · standardAP
2019-08-20Labeling · Supplement 20 · standardAP
2019-08-20Labeling · Supplement 23 · standardAP
2017-07-24Labeling · Supplement 17 · standardAP
2017-03-24Labeling · Supplement 12 · standardAP
2017-03-24Labeling · Supplement 16 · standardAP
2014-12-21Labeling · Supplement 2AP
2014-12-21Labeling · Supplement 11 · standardAP
2011-12-20Labeling · Supplement 8AP
2010-12-22Labeling · Supplement 7AP
2007-06-08Labeling · Supplement 4AP
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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