FDA.reportPublic FDA data

Application 020428

Type
NDA
Sponsor
ALMIRALL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZELEXAZELAIC ACIDCREAM;TOPICAL20%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-8694AZELEXazelaic acidAllergan, Inc.NDACurrent
0023-8694AZELEXazelaic acidAllergan, Inc.NDACurrent
16110-869AZELEXazelaic acidAlmirall, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78029SUPPL 2024-04-02
61523SUPPL2020-01-07
57646ORIG2019-02-15
12576SUPPL2003-06-22
2532SUPPL2003-06-22
34647SUPPL2003-04-30
41356SUPPL2000-06-12
20653SUPPL2000-06-12