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FDA ANDA · ANDA203048

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER

Sponsor: RISING

APPLICATION
ANDA203048
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-04
LATEST ACTION
2020-05-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINERPrescription
CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML · INJECTABLE · INJECTION
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

Approval history

2020-05-14Labeling · Supplement 1 · standardAP
2020-05-14Labeling · Supplement 8 · standardAP
2020-05-14Labeling · Supplement 4 · standardAP
2020-05-14Labeling · Supplement 2 · standardAP
2020-05-14Labeling · Supplement 3 · standardAP
2013-04-04UNKNOWN · OriginalAP
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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