← FDA DRUG APPROVALS

FDA NDA · NDA021704

ALLEGRA-D ALLERGY AND CONGESTION

fexofenadine hydrochloride and pseudoephedrine hydrochloride

Sponsor: CHATTEM SANOFI

APPLICATION
NDA021704
TYPE
NDA
ORIGINAL APPROVAL
2004-10-19
LATEST ACTION
2016-10-31
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter

Products

ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION · ReferenceOver-the-counter
FEXOFENADINE HYDROCHLORIDE 180MG, PSEUDOEPHEDRINE HYDROCHLORIDE 240MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2016-10-31Manufacturing (CMC) · Supplement 20 · standardAP
2016-06-02Labeling · Supplement 18 · standard — Label ↗AP
2015-06-08Efficacy · Supplement 17 · standard — Label ↗AP
2014-01-30Manufacturing (CMC) · Supplement 16 · standardAP
2014-01-06Manufacturing (CMC) · Supplement 14 · standardAP
2013-10-18Manufacturing (CMC) · Supplement 15 · standardAP
2012-12-05Labeling · Supplement 13 · standard — Letter ↗AP
2012-08-23Labeling · Supplement 11 · standard — Letter ↗AP
2012-02-03Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP
2011-01-24Efficacy · Supplement 8 · standard — Label ↗AP
2010-04-14Labeling · Supplement 7 · unknown — Letter ↗AP
2004-10-19Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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