← FDA DRUG APPROVALS

FDA NDA · NDA020872

ALLEGRA HIVES 24HR

fexofenadine hydrochloride

Sponsor: CHATTEM SANOFI

APPLICATION
NDA020872
TYPE
NDA
ORIGINAL APPROVAL
2000-02-25
LATEST ACTION
2023-08-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Over-the-counter

Products

ALLEGRA HIVES · ReferenceDiscontinued
FEXOFENADINE HYDROCHLORIDE 60MG · TABLET · ORAL
CHILDREN'S ALLEGRA HIVES · ReferenceDiscontinued
FEXOFENADINE HYDROCHLORIDE 30MG · TABLET · ORAL
ALLEGRA ALLERGY · ReferenceOver-the-counter
FEXOFENADINE HYDROCHLORIDE 180MG · TABLET · ORAL
ALLEGRA HIVES · ReferenceOver-the-counter
FEXOFENADINE HYDROCHLORIDE 180MG · TABLET · ORAL
ALLEGRA ALLERGY · ReferenceOver-the-counter
FEXOFENADINE HYDROCHLORIDE 60MG · TABLET · ORAL
CHILDREN'S ALLEGRA ALLERGY · ReferenceDiscontinued
FEXOFENADINE HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2023-08-01Manufacturing (CMC) · Supplement 47 · standard — Label ↗AP
2021-10-13Labeling · Supplement 46 · standard — Letter ↗AP
2016-05-10Labeling · Supplement 38 · standard — Letter ↗AP
2016-03-23Manufacturing (CMC) · Supplement 37 · standardAP
2015-09-24Manufacturing (CMC) · Supplement 35 · standardAP
2015-09-18Manufacturing (CMC) · Supplement 36 · standardAP
2014-12-02Manufacturing (CMC) · Supplement 33 · standardAP
2014-09-12Labeling · Supplement 32 · standard — Letter ↗AP
2014-04-16Manufacturing (CMC) · Supplement 31 · standard — Review ↗AP
2013-04-16Manufacturing (CMC) · Supplement 30 · standardAP
2012-08-23Labeling · Supplement 29 · standard — Letter ↗AP
2012-02-23Labeling · Supplement 25 · unknown — Letter ↗AP
2011-01-24Efficacy · Supplement 23 · standard — Letter ↗AP
2008-06-25Labeling · Supplement 18 · standard — Letter ↗AP
2005-10-13Efficacy · Supplement 15 · unknown — Letter ↗AP
2003-05-12Efficacy · Supplement 11 · priority — Letter ↗AP
2003-05-12Efficacy · Supplement 3 · standard — Letter ↗AP
2002-12-10Manufacturing (CMC) · Supplement 9 · standard — Review ↗AP
2002-10-10Manufacturing (CMC) · Supplement 10 · standard — Review ↗AP
2002-02-20Manufacturing (CMC) · Supplement 8 · standard — Review ↗AP
2001-07-11Labeling · Supplement 7 · standard — Letter ↗AP
2001-05-30Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
2001-01-05Manufacturing (CMC) · Supplement 5 · standard — Review ↗AP
2000-04-14Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
2000-03-21Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
2000-02-25Type 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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