FDA.reportPublic FDA data

Application 022395

Type
NDA
Sponsor
AVERITAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUTENZACAPSAICINPATCH;TOPICAL8%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10144-928QutenzacapsaicinAcorda Therapeutics, Inc.NDACurrent
10144-929QutenzacapsaicinAcorda Therapeutics, Inc.NDACurrent
72512-928QutenzacapsaicinAveritas Pharma IncNDACurrent
72512-928QutenzacapsaicinAveritas Pharma IncNDACurrent
72512-928QutenzacapsaicinAveritas Pharma IncNDACurrent
72512-928QutenzacapsaicinAveritas Pharma IncNDACurrent
72512-929QutenzacapsaicinAveritas Pharma IncNDACurrent
72512-929QutenzacapsaicinAveritas Pharma IncNDACurrent
72512-929QutenzacapsaicinAveritas Pharma IncNDACurrent
72512-929QutenzacapsaicinAveritas Pharma IncNDACurrent
72512-930QutenzacapsaicinAveritas Pharma IncNDACurrent
72512-930QutenzacapsaicinAveritas Pharma IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79284SUPPL 2024-08-02
79268SUPPL 2024-08-02
73575SUPPL 2023-02-21
73557SUPPL 2023-02-17
71802SUPPL2022-08-15
71790SUPPL2022-08-12
68312SUPPL2021-08-06
68303SUPPL2021-08-06
64059SUPPL2020-07-23
63973SUPPL2020-07-20
63355SUPPL2020-06-01
63351SUPPL2020-05-29
44746ORIG2010-06-29
22010ORIG2010-06-29
29674ORIG2009-11-19
17309ORIG2009-11-17