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FDA ANDA · ANDA062943

CLINDAMYCIN PHOSPHATE

Sponsor: ALMAJECT

APPLICATION
ANDA062943
TYPE
ANDA
ORIGINAL APPROVAL
1988-09-29
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 32 · standardAP
2026-05-28Labeling · Supplement 30 · standardAP
2026-05-28Labeling · Supplement 29 · standardAP
2026-05-28Labeling · Supplement 27 · standardAP
2026-05-28Labeling · Supplement 31 · standardAP
2013-01-18Labeling · Supplement 24 · standardAP
2008-10-10Labeling · Supplement 20AP
2005-08-12Labeling · Supplement 15AP
2004-04-12Labeling · Supplement 13AP
2001-01-23Manufacturing (CMC) · Supplement 9AP
2000-10-26Labeling · Supplement 8AP
1998-08-03Manufacturing (CMC) · Supplement 7AP
1994-02-23Manufacturing (CMC) · Supplement 6AP
1994-02-09Labeling · Supplement 5AP
1991-10-22Labeling · Supplement 3AP
1991-10-22Labeling · Supplement 2AP
1988-10-18Manufacturing (CMC) · Supplement 1AP
1988-09-29OriginalAP
VIEW ON DRUGS@FDA ↗

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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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