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FDA ANDA · ANDA065195

CLARITHROMYCIN

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA065195
TYPE
ANDA
ORIGINAL APPROVAL
2005-03-11
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 18 · standardAP
2015-12-11Labeling · Supplement 7AP
2015-12-11Labeling · Supplement 13 · standardAP
2012-12-11Labeling · Supplement 12 · standardAP
2012-07-18Labeling · Supplement 11AP
2010-04-27Labeling · Supplement 9AP
2007-05-24Labeling · Supplement 3AP
2005-03-11Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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