APPLICATION
ANDA208084
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-28
LATEST ACTION
2023-09-18
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINERPrescription
CLINDAMYCIN PHOSPHATE EQ 18MG BASE/ML · INJECTABLE · INJECTION
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINERPrescription
CLINDAMYCIN PHOSPHATE EQ 6MG BASE/ML · INJECTABLE · INJECTION
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINERPrescription
CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-09-18Labeling · Supplement 5 · standardAP
2023-09-18Labeling · Supplement 3 · standardAP
2020-05-14Labeling · Supplement 2 · standardAP
2017-06-28UNKNOWN · Original · standardAP
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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