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FDA ANDA · ANDA090108

CLINDAMYCIN

clindamycin phosphate

Sponsor: SAGENT PHARMS INC

APPLICATION
ANDA090108
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-30
LATEST ACTION
2026-07-13
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CLINDAMYCIN PHOSPHATEPrescription
CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML · INJECTABLE · INJECTION

Approval history

2026-07-13Labeling · Supplement 25 · standardAP
2026-07-13Labeling · Supplement 26 · standardAP
2021-02-11Labeling · Supplement 15 · standardAP
2021-02-11Labeling · Supplement 13 · standardAP
2021-02-11Labeling · Supplement 11 · standardAP
2018-04-16Labeling · Supplement 6 · standardAP
2018-04-16Labeling · Supplement 10 · standardAP
2018-04-16Labeling · Supplement 9 · standardAP
2018-04-16Labeling · Supplement 5 · standardAP
2011-09-30OriginalAP
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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