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FDA NDA · NDA020617

PYTEST KIT

Sponsor: AVENT

APPLICATION
NDA020617
TYPE
NDA
ORIGINAL APPROVAL
1997-05-09
LATEST ACTION
2014-01-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PYTEST KIT · ReferenceDiscontinued
UREA, C-14 1uCi **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
PYTEST · ReferenceDiscontinued
UREA, C-14 1uCi · CAPSULE · ORAL

Approval history

2014-01-31Manufacturing (CMC) · Supplement 4AP
2000-03-17Manufacturing (CMC) · Supplement 1 · priorityAP
1997-05-09Type 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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