APPLICATION
ANDA063083
TYPE
ANDA
ORIGINAL APPROVAL
1991-07-31
LATEST ACTION
2026-01-17
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
Approval history
2026-01-17Labeling · Supplement 54 · standardAP
2026-01-17Labeling · Supplement 52 · standardAP
2026-01-17Labeling · Supplement 50 · standardAP
2026-01-17Labeling · Supplement 49 · standardAP
2026-01-17Labeling · Supplement 55 · standardAP
2026-01-17Labeling · Supplement 53 · standardAP
2026-01-17Labeling · Supplement 51 · standardAP
2026-01-17Labeling · Supplement 56 · standardAP
2014-11-12Manufacturing (CMC) · Supplement 47AP
2013-01-18Labeling · Supplement 46 · standardAP
2005-03-09Labeling · Supplement 27AP
2004-03-15Labeling · Supplement 22AP
2003-03-18Labeling · Supplement 19AP
2003-03-18Manufacturing (CMC) · Supplement 15AP
2002-02-19Manufacturing (CMC) · Supplement 14AP
2001-06-29Manufacturing (CMC) · Supplement 13AP
2001-05-01Manufacturing (CMC) · Supplement 10AP
2001-05-01Manufacturing (CMC) · Supplement 11AP
2001-04-25Manufacturing (CMC) · Supplement 12AP
1999-11-29Manufacturing (CMC) · Supplement 8AP
1999-10-06Labeling · Supplement 9AP
1998-12-09Manufacturing (CMC) · Supplement 5AP
1998-09-18Labeling · Supplement 6AP
1997-11-12Manufacturing (CMC) · Supplement 4AP
1997-09-09Manufacturing (CMC) · Supplement 3AP
1996-09-23Manufacturing (CMC) · Supplement 2AP
1993-09-24Manufacturing (CMC) · Supplement 1AP
1991-07-31OriginalAP
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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