APPLICATION
ANDA203584
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-28
LATEST ACTION
2023-08-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLARITHROMYCINPrescription
CLARITHROMYCIN 250MG · TABLET · ORAL
CLARITHROMYCINPrescription
CLARITHROMYCIN 500MG · TABLET · ORAL
Approval history
2023-08-16Labeling · Supplement 24 · standardAP
2023-05-31Labeling · Supplement 13 · standardAP
2023-05-31Labeling · Supplement 9 · standardAP
2023-05-31Labeling · Supplement 5 · standardAP
2023-05-31Labeling · Supplement 18 · standardAP
2023-05-31Labeling · Supplement 20 · standardAP
2023-05-31Labeling · Supplement 2 · standardAP
2015-09-28UNKNOWN · OriginalAP
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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