APPLICATION
ANDA202710
TYPE
ANDA
ORIGINAL APPROVAL
2013-06-10
LATEST ACTION
2023-08-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLARITHROMYCINPrescription
CLARITHROMYCIN 500MG · TABLET · ORAL
CLARITHROMYCINPrescription
CLARITHROMYCIN 250MG · TABLET · ORAL
Approval history
2023-08-16Labeling · Supplement 6 · standardAP
2023-06-28Labeling · Supplement 5 · standardAP
2023-06-28Labeling · Supplement 3 · standardAP
2023-06-28Labeling · Supplement 4 · standardAP
2014-08-28Labeling · Supplement 1 · standardAP
2013-06-10UNKNOWN · OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.