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FDA ANDA · ANDA065283

CLARITHROMYCIN

Sponsor: SANDOZ

APPLICATION
ANDA065283
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-04
LATEST ACTION
2023-08-16
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

CLARITHROMYCINPrescription
CLARITHROMYCIN 125MG/5ML · FOR SUSPENSION · ORAL
CLARITHROMYCINPrescription
CLARITHROMYCIN 250MG/5ML · FOR SUSPENSION · ORAL

Approval history

2023-08-16Labeling · Supplement 25 · standardAP
2023-02-14Labeling · Supplement 17 · standardAP
2023-02-14Labeling · Supplement 16 · standardAP
2023-02-14Labeling · Supplement 22 · standardAP
2015-05-28Labeling · Supplement 13 · standardAP
2015-05-28Labeling · Supplement 14 · standardAP
2015-05-28Labeling · Supplement 12 · standardAP
2013-04-18Labeling · Supplement 9 · standardAP
2010-12-22Labeling · Supplement 8AP
2009-03-04Labeling · Supplement 6AP
2008-09-18Labeling · Supplement 4AP
2007-09-04Original — 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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