FDA.reportPublic FDA data

Application 208081

Type
NDA
Sponsor
BIOFRONTERA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMELUZAMINOLEVULINIC ACID HYDROCHLORIDEGEL;TOPICAL10%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70621-101AMELUZaminolevulinic acid hydrochlorideBiofrontera Inc.NDACurrent
70621-101AMELUZaminolevulinic acid hydrochlorideBiofrontera Inc.NDACurrent
70621-101AMELUZaminolevulinic acid hydrochlorideBiofrontera Inc.NDACurrent
70621-101AMELUZaminolevulinic acid hydrochlorideBiofrontera Inc.NDACurrent
70621-101AMELUZaminolevulinic acid hydrochlorideBiofrontera Inc.NDACurrent
70621-101AMELUZaminolevulinic acid hydrochlorideBiofrontera Inc.NDACurrent
70621-101AMELUZaminolevulinic acid hydrochlorideBiofrontera Inc.NDACurrent
70621-101AMELUZaminolevulinic acid hydrochlorideBiofrontera Inc.NDACurrent
70621-101AMELUZaminolevulinic acid hydrochlorideBiofrontera Inc.NDACurrent
70621-101AMELUZaminolevulinic acid hydrochlorideBiofrontera Inc.NDACurrent
70621-101AMELUZaminolevulinic acid hydrochlorideBiofrontera Inc.NDACurrent
70621-101AMELUZaminolevulinic acid hydrochlorideBiofrontera Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79830SUPPL 2024-10-07
79824SUPPL 2024-10-07
77868SUPPL 2024-03-19
77859SUPPL 2024-03-18
67605SUPPL2021-05-27
67599SUPPL2021-05-26
49702SUPPL2017-09-08
49683SUPPL2017-09-07
47165ORIG2017-02-10
10643ORIG2016-05-16
19984ORIG2016-05-11