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FDA NDA · NDA050824

OMECLAMOX-PAK

Sponsor: CUMBERLAND

APPLICATION
NDA050824
TYPE
NDA
ORIGINAL APPROVAL
2011-02-08
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE, TABLET, CAPSULE, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

OMECLAMOX-PAK · ReferenceDiscontinued
AMOXICILLIN 500MG,N/A,N/A, CLARITHROMYCIN N/A,500MG,N/A, OMEPRAZOLE N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, TABLET, CAPSULE, DELAYED RELEASE · ORAL

Approval history

2024-05-01Labeling · Supplement 13 · standard — Letter ↗AP
2023-08-16Labeling · Supplement 11 · standard — Letter ↗AP
2023-08-16Labeling · Supplement 12 · standard — Letter ↗AP
2022-03-04Labeling · Supplement 10 · standard — Letter ↗AP
2020-11-27Labeling · Supplement 9 · standard — Label ↗AP
2020-01-17Labeling · Supplement 7 · standard — Label ↗AP
2016-10-24Labeling · Supplement 6 · 901 required — Letter ↗AP
2016-02-26Manufacturing (CMC) · Supplement 5 · standardAP
2014-12-29Labeling · Supplement 4 · 901 required — Label ↗AP
2011-09-07Labeling · Supplement 3 · standardAP
2011-02-08Type 3 - New Dosage Form · Original · standard — Other ↗AP
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