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FDA ANDA · ANDA065144

CLARITHROMYCIN

Sponsor: SANDOZ

APPLICATION
ANDA065144
TYPE
ANDA
ORIGINAL APPROVAL
2005-10-18
LATEST ACTION
2023-08-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CLARITHROMYCINPrescription
CLARITHROMYCIN 250MG · TABLET · ORAL

Approval history

2023-08-16Labeling · Supplement 31 · standardAP
2023-05-18Labeling · Supplement 24 · standardAP
2023-05-18Labeling · Supplement 19 · standardAP
2023-05-18Labeling · Supplement 21 · standardAP
2023-05-18Labeling · Supplement 28 · standardAP
2023-05-18Labeling · Supplement 26 · standardAP
2015-07-01Labeling · Supplement 16 · standardAP
2015-07-01Labeling · Supplement 17 · standardAP
2015-07-01Labeling · Supplement 15 · standardAP
2012-12-11Labeling · Supplement 14 · standardAP
2008-08-22Labeling · Supplement 11AP
2008-04-09Labeling · Supplement 7AP
2007-10-17Labeling · Supplement 6AP
2005-10-18Original — 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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