FDA.reportPublic FDA data

Application 202450

Type
NDA
Sponsor
CIRCASSIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TUDORZA PRESSAIRACLIDINIUM BROMIDEPOWDER, METERED;INHALATION0.4MG/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-0800Tudorza Pressairaclidinium bromideAstraZeneca Pharmaceuticals LPNDACurrent
0310-0800Tudorza Pressairaclidinium bromideAstraZeneca Pharmaceuticals LPNDACurrent
0310-0800Tudorza Pressairaclidinium bromideAstraZeneca Pharmaceuticals LPNDACurrent
0310-0800Tudorza Pressairaclidinium bromideAstraZeneca Pharmaceuticals LPNDACurrent
0310-0800Tudorza Pressairaclidinium bromideAstraZeneca Pharmaceuticals LPNDACurrent
0310-0800Tudorza Pressairaclidinium bromideAstraZeneca PharmaceuticaNDACurrent
0310-0800Tudorza Pressairaclidinium bromideAstraZeneca Pharmaceuticals LPNDACurrent
0310-0800Tudorza Pressairaclidinium bromideAstraZeneca Pharmaceuticals LPNDACurrent
0310-0800Tudorza Pressairaclidinium bromideAstraZeneca Pharmaceuticals LPNDACurrent
72124-002Tudorza Pressairaclidinium bromideCircassia Pharmaceuticals Inc.NDACurrent
72124-002Tudorza Pressairaclidinium bromideCircassia Pharmaceuticals Inc.NDACurrent
72124-002Tudorza Pressairaclidinium bromideCircassia Pharmaceuticals Inc.NDACurrent
72124-002Tudorza Pressairaclidinium bromideCircassia Pharmaceuticals Inc.NDACurrent
72124-002Tudorza Pressairaclidinium bromideCircassia Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58158SUPPL2019-04-01
58142SUPPL2019-03-29
56469SUPPL2018-11-15
56417SUPPL2018-11-13
32264SUPPL2016-03-18
40186SUPPL2016-03-17
19352SUPPL2015-04-07
32263SUPPL2015-04-06
10054SUPPL2014-11-03
19351SUPPL2014-07-22
10053SUPPL2014-07-21
43403ORIG2012-09-05
24418ORIG2012-09-05
10052ORIG2012-07-25
19350ORIG2012-07-24