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FDA NDA · NDA021412

TOVALT ODT

Sponsor: BIOVAIL LABS INTL

APPLICATION
NDA021412
TYPE
NDA
ORIGINAL APPROVAL
2007-04-25
LATEST ACTION
2007-04-25
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

TOVALT ODT · ReferenceDiscontinued
ZOLPIDEM TARTRATE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
TOVALT ODT · ReferenceDiscontinued
ZOLPIDEM TARTRATE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2007-04-25Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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