FDA.reportPublic FDA data

Application 021794

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACZONEDAPSONEGEL;TOPICAL5%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-3670ACZONEdapsoneAllergan, Inc.NDACurrent
0023-3670ACZONEdapsoneAllergan, Inc.NDACurrent
0023-3670ACZONEdapsoneAllergan, Inc.NDACurrent
0023-3670ACZONEdapsoneAllergan, Inc.NDACurrent
16110-367ACZONEdapsoneALMIRALL, LLCNDACurrent
16110-367AczonedapsoneAlmirall, LLCNDACurrent
60758-670DAPSONEdapsonePacific Pharma, Inc.NDACurrent
60758-670DAPSONEdapsonePacific Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54283SUPPL2018-05-22
54277SUPPL2018-05-21
37659SUPPL2015-07-24
28610SUPPL2015-07-13
37658SUPPL2009-04-03
6198SUPPL2008-03-18
37657SUPPL2008-03-17
21820ORIG2007-09-13
6197ORIG2005-07-15
37656ORIG2005-07-08