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FDA NDA · NDA021082

TAVIST ALLERGY/SINUS/HEADACHE

Sponsor: NOVARTIS

APPLICATION
NDA021082
TYPE
NDA
ORIGINAL APPROVAL
2001-03-01
LATEST ACTION
2002-06-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TAVIST ALLERGY/SINUS/HEADACHEDiscontinued
ACETAMINOPHEN 500MG, CLEMASTINE FUMARATE EQ 0.25MG BASE, PSEUDOEPHEDRINE HYDROCHLORIDE 30MG · TABLET · ORAL

Approval history

2002-06-12Manufacturing (CMC) · Supplement 2 · standardAP
2001-12-03Manufacturing (CMC) · Supplement 1 · standardAP
2001-03-01Type 4 - New Combination · Original · standard — Letter ↗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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