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FDA ANDA · ANDA065155

CLARITHROMYCIN

Sponsor: TEVA

APPLICATION
ANDA065155
TYPE
ANDA
ORIGINAL APPROVAL
2005-05-31
LATEST ACTION
2023-08-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CLARITHROMYCINDiscontinued
CLARITHROMYCIN 250MG · TABLET · ORAL
CLARITHROMYCINDiscontinued
CLARITHROMYCIN 500MG · TABLET · ORAL

Approval history

2023-08-16Labeling · Supplement 21 · standardAP
2023-07-10Labeling · Supplement 13 · standardAP
2023-07-10Labeling · Supplement 14 · standardAP
2023-07-10Labeling · Supplement 20 · standardAP
2023-07-10Labeling · Supplement 17 · standardAP
2023-07-10Labeling · Supplement 15 · standardAP
2012-12-11Labeling · Supplement 11 · standardAP
2012-07-18Labeling · Supplement 9 · standardAP
2012-03-30Labeling · Supplement 7AP
2012-03-30Labeling · Supplement 8AP
2012-02-13Manufacturing (CMC) · Supplement 4AP
2010-08-20Labeling · Supplement 5AP
2009-03-04Labeling · Supplement 3AP
2008-06-30Labeling · Supplement 2AP
2006-05-08Labeling · Supplement 1AP
2005-05-31Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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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