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FDA NDA · NDA201373

CHILDRENS ALLEGRA HIVES

fexofenadine hcl

Sponsor: CHATTEM SANOFI

APPLICATION
NDA201373
TYPE
NDA
ORIGINAL APPROVAL
2011-01-24
LATEST ACTION
2022-12-27
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued, Over-the-counter

Products

CHILDREN'S ALLEGRA HIVES · ReferenceDiscontinued
FEXOFENADINE HYDROCHLORIDE 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION · ORAL
CHILDREN'S ALLEGRA ALLERGY · ReferenceOver-the-counter
FEXOFENADINE HYDROCHLORIDE 30MG/5ML · SUSPENSION · ORAL

Approval history

2022-12-27Manufacturing (CMC) · Supplement 13 — Letter ↗AP
2022-12-20Manufacturing (CMC) · Supplement 12 — Letter ↗AP
2021-03-17Manufacturing (CMC) · Supplement 11 — Letter ↗AP
2020-11-02Labeling · Supplement 10 · standard — Letter ↗AP
2016-06-15Labeling · Supplement 6 · standard — Letter ↗AP
2013-04-28Labeling · Supplement 5 · standard — Label ↗AP
2012-08-23Labeling · Supplement 4 · standard — Letter ↗AP
2012-02-23Labeling · Supplement 2 · standard — Letter ↗AP
2011-01-24Type 8 - Partial Rx to OTC Switch · Original · standard — Label ↗AP
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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