APPLICATION
ANDA065145
TYPE
ANDA
ORIGINAL APPROVAL
2004-06-24
LATEST ACTION
2023-08-16
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
CLARITHROMYCINPrescription
CLARITHROMYCIN 500MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-08-16Labeling · Supplement 43 · standardAP
2023-08-15Labeling · Supplement 36 · standardAP
2023-08-15Labeling · Supplement 40 · standardAP
2023-08-15Labeling · Supplement 37 · standardAP
2023-08-15Labeling · Supplement 35 · standardAP
2015-03-02Labeling · Supplement 31 · standardAP
2015-03-02Labeling · Supplement 34 · standardAP
2015-03-02Labeling · Supplement 33 · standardAP
2012-12-11Labeling · Supplement 30 · standardAP
2011-07-07Labeling · Supplement 25AP
2010-03-10Labeling · Supplement 21AP
2008-01-30Labeling · Supplement 10AP
2006-05-10Labeling · Supplement 7AP
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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