← FDA DRUG APPROVALS

FDA NDA · NDA020786

ALLEGRA-D ALLERGY AND CONGESTION

fexofenadine hydrochloride and pseudoephedrine hydrochloride

Sponsor: CHATTEM SANOFI

APPLICATION
NDA020786
TYPE
NDA
ORIGINAL APPROVAL
1997-12-24
LATEST ACTION
2016-10-31
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter

Products

ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION · ReferenceOver-the-counter
FEXOFENADINE HYDROCHLORIDE 60MG, PSEUDOEPHEDRINE HYDROCHLORIDE 120MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2016-10-31Manufacturing (CMC) · Supplement 39 · standardAP
2016-10-31Manufacturing (CMC) · Supplement 36 · standardAP
2016-06-02Labeling · Supplement 35 · standard — Letter ↗AP
2015-07-09Manufacturing (CMC) · Supplement 34 · standardAP
2015-06-08Efficacy · Supplement 33 · standard — Label ↗AP
2014-05-14Manufacturing (CMC) · Supplement 32 · standardAP
2012-12-05Labeling · Supplement 31 · standard — Label ↗AP
2012-08-23Labeling · Supplement 29 · standard — Letter ↗AP
2012-02-03Manufacturing (CMC) · Supplement 28 · standard — Letter ↗AP
2011-01-24Efficacy · Supplement 27 · standard — Label ↗AP
2010-04-14Labeling · Supplement 26 · unknown — Letter ↗AP
2004-12-06Labeling · Supplement 17 · standardAP
2003-05-12Efficacy · Supplement 14 · priority — Label ↗AP
2002-11-01Labeling · Supplement 12 · standard — Review ↗AP
2002-10-29Manufacturing (CMC) · Supplement 11 · standardAP
2001-10-31Manufacturing (CMC) · Supplement 13 · standardAP
2001-01-19Manufacturing (CMC) · Supplement 9 · standard — Review ↗AP
2000-09-26Manufacturing (CMC) · Supplement 8 · standardAP
2000-01-21Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
2000-01-06Manufacturing (CMC) · Supplement 6 · standard — Review ↗AP
1999-12-21Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
1999-12-01Manufacturing (CMC) · Supplement 5 · standard — Review ↗AP
1998-12-22Labeling · Supplement 3 · standard — Review ↗AP
1998-07-06Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
1997-12-24Type 4 - New Combination · 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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