APPLICATION
ANDA065154
TYPE
ANDA
ORIGINAL APPROVAL
2005-05-18
LATEST ACTION
2023-08-17
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
CLARITHROMYCINPrescription
CLARITHROMYCIN 500MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-08-17Labeling · Supplement 19 · standardAP
2023-08-17Labeling · Supplement 17 · standardAP
2023-08-17Labeling · Supplement 15 · standardAP
2023-08-17Labeling · Supplement 16 · standardAP
2023-08-16Labeling · Supplement 20 · standardAP
2015-12-16Labeling · Supplement 14 · standardAP
2015-12-16Labeling · Supplement 12 · standardAP
2015-12-16Labeling · Supplement 13 · standardAP
2015-12-16Labeling · Supplement 11 · standardAP
2012-12-11Labeling · Supplement 9 · standardAP
2012-07-19Labeling · Supplement 8 · standardAP
2012-03-28Labeling · Supplement 7AP
2010-08-20Labeling · Supplement 5AP
2008-10-22Labeling · Supplement 4AP
2008-06-30Labeling · Supplement 3AP
2006-05-10Labeling · Supplement 1AP
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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