APPLICATION
ANDA065061
TYPE
ANDA
ORIGINAL APPROVAL
2001-02-02
LATEST ACTION
2025-07-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CLINDAMYCIN HYDROCHLORIDEPrescription
CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE · CAPSULE · ORAL
CLINDAMYCIN HYDROCHLORIDEPrescription
CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE · CAPSULE · ORAL
Approval history
2025-07-01Labeling · Supplement 56 · standardAP
2023-09-12Labeling · Supplement 49 · standardAP
2023-09-12Labeling · Supplement 46 · standardAP
2019-08-19Labeling · Supplement 32 · standardAP
2019-08-19Labeling · Supplement 29 · standardAP
2019-08-19Labeling · Supplement 33 · standardAP
2019-08-19Labeling · Supplement 44 · standardAP
2019-08-19Labeling · Supplement 28 · standardAP
2014-12-21Labeling · Supplement 24 · standardAP
2013-01-29Labeling · Supplement 18AP
2013-01-29Labeling · Supplement 17AP
2007-07-10Labeling · Supplement 10AP
2005-10-26Labeling · Supplement 6AP
2004-03-10Labeling · Supplement 4AP
2002-03-15Manufacturing (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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