APPLICATION
ANDA091225
TYPE
ANDA
ORIGINAL APPROVAL
2011-05-31
LATEST ACTION
2025-05-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
CLINDAMYCIN HYDROCHLORIDEDiscontinued
CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE · CAPSULE · ORAL
CLINDAMYCIN HYDROCHLORIDEDiscontinued
CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE · CAPSULE · ORAL
CLINDAMYCIN HYDROCHLORIDEDiscontinued
CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE · CAPSULE · ORAL
Approval history
2025-05-23Labeling · Supplement 8 · standardAP
2023-09-14Labeling · Supplement 6 · standardAP
2023-09-14Labeling · Supplement 4 · standardAP
2023-09-14Labeling · Supplement 2 · standardAP
2023-09-14Labeling · Supplement 7 · standardAP
2023-09-14Labeling · Supplement 5 · standardAP
2023-09-14Labeling · Supplement 3 · standardAP
2013-03-11Labeling · Supplement 1 · standardAP
2011-05-31OriginalAP
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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