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FDA NDA · NDA018675

TAVIST

Sponsor: NOVARTIS

APPLICATION
NDA018675
TYPE
NDA
ORIGINAL APPROVAL
1985-06-28
LATEST ACTION
2002-02-11
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

TAVIST · ReferenceDiscontinued
CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL

Approval history

2002-02-11Manufacturing (CMC) · Supplement 10 · standardAP
1995-06-14Manufacturing (CMC) · Supplement 7 · standardAP
1994-08-30Labeling · Supplement 6 · standardAP
1994-07-21Manufacturing (CMC) · Supplement 4 · standardAP
1987-12-04Manufacturing (CMC) · Supplement 2 · standardAP
1986-12-02Manufacturing (CMC) · Supplement 1 · standardAP
1985-06-28Type 3 - New Dosage Form · 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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