APPLICATION
ANDA062803
TYPE
ANDA
ORIGINAL APPROVAL
1987-10-16
LATEST ACTION
2017-09-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CLEOCIN PHOSPHATEPrescription
CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML · INJECTABLE · INJECTION
Approval history
2017-09-11Labeling · Supplement 35 · standardAP
2016-08-18Labeling · Supplement 27 · standardAP
2016-08-18Labeling · Supplement 25 · standardAP
2016-08-18Labeling · Supplement 31 · standardAP
2016-08-18Labeling · Supplement 26 · standardAP
2016-08-18Labeling · Supplement 32 · standardAP
2000-04-05Manufacturing (CMC) · Supplement 12AP
1998-10-01Labeling · Supplement 11AP
1998-01-12Labeling · Supplement 6AP
1996-04-30Labeling · Supplement 4AP
1996-02-02Manufacturing (CMC) · Supplement 10AP
1993-09-23Labeling · Supplement 8AP
1992-10-30Manufacturing (CMC) · Supplement 9AP
1992-07-06Manufacturing (CMC) · Supplement 5AP
1990-03-22Manufacturing (CMC) · Supplement 3AP
1987-10-16OriginalAP
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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