APPLICATION
ANDA065489
TYPE
ANDA
ORIGINAL APPROVAL
2012-07-25
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 24 · standardAP
2023-02-14Labeling · Supplement 18 · standardAP
2023-02-14Labeling · Supplement 10 · standardAP
2023-02-14Labeling · Supplement 17 · standardAP
2023-02-14Labeling · Supplement 15 · standardAP
2023-02-14Labeling · Supplement 21 · standardAP
2023-02-14Labeling · Supplement 13 · standardAP
2016-01-21Labeling · Supplement 6 · standardAP
2016-01-21Labeling · Supplement 4 · standardAP
2016-01-21Labeling · Supplement 9 · standardAP
2016-01-21Labeling · Supplement 7 · standardAP
2012-07-25OriginalAP
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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