FDA.reportPublic FDA data

Application 020468

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002NASACORT ALLERGY 24 HOURTRIAMCINOLONE ACETONIDESPRAY, METERED;NASAL0.055MG/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
41167-5800Nasacort Allergy 24HRTriamcinolone AcetonideChattem, Inc.NDACurrent
41167-5800Nasacort Allergy 24HRTriamcinolone AcetonideChattem, Inc.NDACurrent
41167-5800Nasacort Allergy 24HRTriamcinolone AcetonideChattem, Inc.NDACurrent
41167-5800Nasacort Allergy 24HRTriamcinolone AcetonideChattem, Inc.NDACurrent
41167-5900Childrens Nasacort Allergy 24HRTriamcinolone AcetonideChattem, Inc.NDACurrent
41167-5900Childrens Nasacort Allergy 24HRTriamcinolone AcetonideChattem, Inc.NDACurrent
50090-1444Nasacort Allergy 24HRTriamcinolone AcetonideA-S Medication SolutionsNDACurrent
50090-1444Nasacort Allergy 24HRTriamcinolone AcetonideA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82194SUPPL 2025-05-15
82190SUPPL 2025-05-15
56100SUPPL2018-10-26
56055SUPPL2018-10-23
51868SUPPL2018-01-26
51430SUPPL2018-01-22
45531SUPPL2016-10-12
45603SUPPL2016-10-11
12613SUPPL2015-06-22
2571SUPPL2015-06-22
34680SUPPL2014-09-23
25003SUPPL2014-09-23
12612SUPPL2013-10-15
25002SUPPL2013-10-11
34679SUPPL2013-07-03
25001SUPPL2013-07-03
12611SUPPL2013-07-03
2570SUPPL2013-07-03
12610SUPPL2008-09-25
2569SUPPL2008-09-23
41379SUPPL2008-08-11
12609SUPPL2004-04-05
2568SUPPL2004-03-10
34678SUPPL2004-01-15
2567SUPPL2004-01-09
12608SUPPL2003-12-29
25000SUPPL2003-12-22
53430SUPPL1900-01-01
53429SUPPL1900-01-01
53428SUPPL1900-01-01