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FDA ANDA · ANDA065178

CLARITHROMYCIN

Sponsor: HIKMA

APPLICATION
ANDA065178
TYPE
ANDA
ORIGINAL APPROVAL
2004-05-25
LATEST ACTION
2023-08-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2023-08-16Labeling · Supplement 17 · standardAP
2019-12-17Labeling · Supplement 15 · standardAP
2019-12-17Labeling · Supplement 16 · standardAP
2019-12-17Labeling · Supplement 14 · standardAP
2015-02-13Labeling · Supplement 13 · standardAP
2015-02-13Labeling · Supplement 11 · standardAP
2015-02-13Labeling · Supplement 12 · standardAP
2012-12-11Labeling · Supplement 10 · standardAP
2012-07-18Labeling · Supplement 7AP
2012-07-18Labeling · Supplement 8 · standardAP
2007-06-20Labeling · Supplement 6AP
2007-03-08Labeling · Supplement 5AP
2005-04-20Labeling · Supplement 1AP
2004-05-25Original — 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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