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FDA NDA · NDA016758

NAVANE

Sponsor: PFIZER

APPLICATION
NDA016758
TYPE
NDA
ORIGINAL APPROVAL
1970-04-06
LATEST ACTION
2009-07-19
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued

Products

NAVANE · ReferenceDiscontinued
THIOTHIXENE HYDROCHLORIDE EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CONCENTRATE · ORAL

Approval history

2009-07-19Labeling · Supplement 20 · standard — Letter ↗AP
2008-04-07Labeling · Supplement 19 · standard — Letter ↗AP
2003-05-19Labeling · Supplement 17 · standard — Label ↗AP
2001-07-31Labeling · Supplement 11 · standard — Letter ↗AP
2001-07-31Labeling · Supplement 16 · standard — Letter ↗AP
1980-12-10Labeling · Supplement 7AP
1975-05-01Manufacturing (CMC) · Supplement 4 · standardAP
1970-04-06Type 2 - New Active Ingredient · Original · standardAP
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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