Application 021909

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CHILDREN'S ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDETABLET, ORALLY DISINTEGRATING;ORAL30MGYesNo
003CHILDREN'S ALLEGRA HIVESFEXOFENADINE HYDROCHLORIDETABLET, ORALLY DISINTEGRATING;ORAL30MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
41167-4232Childrens Allegra AllergyFexofenadine HydrochlorideChattem, Inc.NDACurrent
41167-4232Childrens Allegra AllergyFexofenadine HydrochlorideChattem, Inc.NDACurrent
41167-4232Childrens Allegra AllergyFexofenadine HydrochlorideChattem, Inc.NDACurrent
41167-4232Childrens Allegra AllergyFexofenadine HydrochlorideChattem, Inc.NDACurrent
41167-4232Childrens Allegra AllergyFexofenadine HydrochlorideChattem, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65924SUPPL2021-01-19
65509SUPPL2020-12-07
37866SUPPL2016-06-17
6436SUPPL2016-06-14
37865SUPPL2013-11-26
16560SUPPL2013-11-21
28829SUPPL2013-04-30
6435SUPPL2012-08-27
28828SUPPL2011-01-27
42347ORIG2009-03-12
28827ORIG2007-07-30
16559ORIG2007-07-30