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FDA NDA · NDA050459

AMOXIL

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APPLICATION
NDA050459
TYPE
NDA
ORIGINAL APPROVAL
1974-01-18
LATEST ACTION
1974-01-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

AMOXIL · ReferenceDiscontinued
AMOXICILLIN 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
AMOXIL · ReferenceDiscontinued
AMOXICILLIN 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

1974-01-18Type 1 - New Molecular Entity · Original · priorityAP
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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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