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FDA ANDA · ANDA200218
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
Sponsor: ANI PHARMS
APPLICATION
ANDA200218
TYPE
ANDA
ORIGINAL APPROVAL
2013-08-30
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Discontinued
Products
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)Discontinued
AMOXICILLIN 500MG, CLARITHROMYCIN 500MG, LANSOPRAZOLE 30MG · CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2024-05-01Labeling · Supplement 12 · standardAP
2023-08-16Labeling · Supplement 11 · standardAP
2023-07-18Labeling · Supplement 10 · standardAP
2022-03-10Labeling · Supplement 9 · standardAP
2022-03-04Labeling · Supplement 7 · standardAP
2022-03-04Labeling · Supplement 6 · standardAP
2015-02-25Labeling · Supplement 5 · standardAP
2015-02-25Labeling · Supplement 3 · standardAP
2013-08-30Not Applicable · 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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