FDA.reportPublic FDA data

Application 021184

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAZORACTAZAROTENECREAM;TOPICAL0.05%YesYes
002TAZORACTAZAROTENECREAM;TOPICAL0.1%YesYes
003AVAGETAZAROTENECREAM;TOPICAL0.1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-9155TAZORACtazaroteneAllergan, Inc.NDACurrent
0023-9155TAZORACtazaroteneAllergan, Inc.NDACurrent
0023-9155TAZORACtazaroteneAllergan, Inc.NDACurrent
0023-9156TAZORACtazaroteneAllergan, Inc.NDACurrent
0023-9156TAZORACtazaroteneAllergan, Inc.NDACurrent
0023-9156TAZORACtazaroteneAllergan, Inc.NDACurrent
0023-9236AVAGEtazaroteneAllergan, Inc.NDACurrent
0023-9236AVAGEtazaroteneAllergan, Inc.NDACurrent
16110-915TAZORACtazaroteneAlmirall, LLCNDACurrent
16110-915TAZORACtazaroteneAlmirall, LLCNDACurrent
16110-916TAZORACtazaroteneAlmirall, LLCNDACurrent
16110-916TAZORACtazaroteneAlmirall, LLCNDACurrent
60758-556TazaroteneTazarotenePacific Pharma, Inc.NDACurrent
60758-556TazaroteneTazarotenePacific Pharma, Inc.NDACurrent
60758-556TazaroteneTazarotenePacific Pharma, Inc.NDACurrent
60758-561TazaroteneTazarotenePacific Pharma, Inc.NDACurrent
60758-561TazaroteneTazarotenePacific Pharma, Inc.NDACurrent
60758-561TazaroteneTazarotenePacific Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49076SUPPL2017-07-25
49052SUPPL2017-07-25
45350SUPPL2016-11-09
45315SUPPL2016-09-16
27022SUPPL2013-12-17
14606SUPPL2013-12-17
27021SUPPL2004-05-27
14605SUPPL2004-05-27
42009ORIG2004-03-28
21497SUPPL2004-01-15
42010SUPPL2001-12-12
14604SUPPL2001-10-24
4595SUPPL2001-10-24
36313ORIG2000-09-29
27020ORIG2000-09-29