FDA.reportPublic FDA data

Application 022134

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LASTACAFTALCAFTADINESOLUTION/DROPS;OPHTHALMIC0.25%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-4290LASTACAFTalcaftadineAllergan, Inc.NDACurrent
0023-4290LASTACAFTalcaftadineAllergan, Inc.NDACurrent
0023-4290LASTACAFTalcaftadineAllergan, Inc.NDACurrent
0023-4290LASTACAFTalcaftadineAllergan, Inc.NDACurrent
0023-4290LASTACAFTalcaftadineAllergan, Inc.NDACurrent
0023-4291LASTACAFTalcaftadineAllergan, Inc.NDACurrent
0023-4291LASTACAFTalcaftadineAllergan, Inc.NDACurrent
0023-4291LASTACAFTalcaftadineAllergan, Inc.NDACurrent
42254-288LASTACAFTalcaftadineRebel Distributors CorpNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71965SUPPL2022-08-30
69575SUPPL2021-12-15
69540SUPPL2021-12-13
63535SUPPL2020-06-12
63476SUPPL2020-06-10
17001SUPPL2015-10-07
6948SUPPL2015-10-02
38295SUPPL2014-12-10
29305SUPPL2014-12-05
24249ORIG2011-02-17
21945ORIG2010-08-23
38294ORIG2010-07-31
29304ORIG2010-07-30
53165ORIG1900-01-01
53164ORIG1900-01-01
53163ORIG1900-01-01