APPLICATION
ANDA065412
TYPE
ANDA
ORIGINAL APPROVAL
2012-02-17
LATEST ACTION
2024-12-23
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
CEFACLORPrescription
CEFACLOR EQ 125MG BASE/5ML · FOR SUSPENSION · ORAL
CEFACLORPrescription
CEFACLOR EQ 375MG BASE/5ML · FOR SUSPENSION · ORAL
CEFACLORPrescription
CEFACLOR EQ 187MG BASE/5ML · FOR SUSPENSION · ORAL
CEFACLORPrescription
CEFACLOR EQ 250MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
2024-12-23Manufacturing (CMC) · Supplement 7 · unknownAP
2015-10-14Labeling · Supplement 1 · standardAP
2012-02-17OriginalAP
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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