FDA.reportPublic FDA data

Application 090824

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADAPALENEADAPALENECREAM;TOPICAL0.1%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090824-001ADAPALENEADAPALENE0.1%CREAM / TOPICALAB2010-06-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A090824-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090824-001ADAPALENE0.1%CREAM / TOPICALAB2010-06-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090824-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AdapaleneADAPALENEBryant Ranch Prepack5f8189a2-a7ec-441b-993c-fed28b3ae24f2026-04-15Adverse reactionsExact identifier
application applno (ANDA): 090824
application number: ANDA090824
ndc (product): 63629-8791
AdapaleneADAPALENEBryant Ranch Prepack79454b4c-3fd4-4e6d-b984-908f8cc8ab6d2026-04-07Adverse reactionsExact identifier
application applno (ANDA): 090824
application number: ANDA090824
AdapaleneADAPALENEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC276f7cce-5f54-40f8-8321-9192d0e52a732026-01-30Adverse reactionsExact identifier
application applno (ANDA): 090824
application number: ANDA090824
ndc (product): 0168-0424

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0424AdapaleneadapaleneE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0424AdapaleneadapaleneE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
63629-8791AdapaleneadapaleneBryant Ranch PrepackANDACurrent
63629-8791AdapaleneadapaleneBryant Ranch PrepackANDACurrent
63629-8791AdapaleneadapaleneBryant Ranch PrepackANDACurrent
68308-706AdapaleneadapaleneMayne Pharma Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31500ORIG2010-07-02