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FDA NDA · NDA012283

HYGROTON

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APPLICATION
NDA012283
TYPE
NDA
ORIGINAL APPROVAL
1960-04-07
LATEST ACTION
1960-04-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYGROTON · ReferenceDiscontinued
CHLORTHALIDONE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
HYGROTON · ReferenceDiscontinued
CHLORTHALIDONE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

1960-04-07Type 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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