← FDA DRUG APPROVALS

FDA NDA · NDA021726

NIRAVAM

Sponsor: UCB INC

APPLICATION
NDA021726
TYPE
NDA
ORIGINAL APPROVAL
2005-01-19
LATEST ACTION
2012-12-14
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

NIRAVAM · ReferenceDiscontinued
ALPRAZOLAM 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
NIRAVAM · ReferenceDiscontinued
ALPRAZOLAM 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
NIRAVAM · ReferenceDiscontinued
ALPRAZOLAM 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
NIRAVAM · ReferenceDiscontinued
ALPRAZOLAM 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2012-12-14Manufacturing (CMC) · Supplement 11 · standardAP
2011-06-16Labeling · Supplement 8 · standard — Letter ↗AP
2006-02-06Manufacturing (CMC) · Supplement 6 — Label ↗AP
2005-01-19Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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