APPLICATION
ANDA062801
TYPE
ANDA
ORIGINAL APPROVAL
1987-07-24
LATEST ACTION
2026-05-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CLINDAMYCIN PHOSPHATEDiscontinued
CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML · INJECTABLE · INJECTION
Approval history
2026-05-28Labeling · Supplement 35 · standardAP
2026-05-28Labeling · Supplement 33 · standardAP
2026-05-28Labeling · Supplement 31 · standardAP
2026-05-28Labeling · Supplement 36 · standardAP
2026-05-28Labeling · Supplement 34 · standardAP
2015-06-13Labeling · Supplement 30 · standardAP
2013-01-18Labeling · Supplement 27 · standardAP
2008-10-08Labeling · Supplement 23AP
2005-08-12Labeling · Supplement 19AP
2004-04-16Labeling · Supplement 17AP
2001-04-09Manufacturing (CMC) · Supplement 15AP
2001-01-23Manufacturing (CMC) · Supplement 14AP
2000-10-26Labeling · Supplement 13AP
1999-02-19Manufacturing (CMC) · Supplement 10AP
1999-02-19Manufacturing (CMC) · Supplement 11AP
1998-08-03Manufacturing (CMC) · Supplement 12AP
1995-05-10Manufacturing (CMC) · Supplement 9AP
1994-03-11Labeling · Supplement 7AP
1994-02-24Manufacturing (CMC) · Supplement 8AP
1992-10-30Manufacturing (CMC) · Supplement 6AP
1991-10-22Labeling · Supplement 3AP
1990-02-08Manufacturing (CMC) · Supplement 4AP
1987-07-24OriginalAP
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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