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FDA ANDA · ANDA202588
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
Sponsor: SANDOZ
APPLICATION
ANDA202588
TYPE
ANDA
ORIGINAL APPROVAL
2014-03-04
LATEST ACTION
2024-06-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)Prescription
AMOXICILLIN 500MG, CLARITHROMYCIN 500MG, LANSOPRAZOLE 30MG · CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2024-06-18Labeling · Supplement 12 · standardAP
2023-08-16Labeling · Supplement 11 · standardAP
2023-07-18Labeling · Supplement 10 · standardAP
2022-08-18Labeling · Supplement 6 · standardAP
2022-03-04Labeling · Supplement 1 · standardAP
2022-03-04Labeling · Supplement 4 · standardAP
2014-03-04UNKNOWN · 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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