FDA.reportPublic FDA data

Application 020338

Type
NDA
Sponsor
GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIFFERINADAPALENESOLUTION;TOPICAL0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N020338-001DIFFERINADAPALENE0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD1996-05-31

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020338-001DIFFERIN0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD1996-05-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020338-001DIFFERIN0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD1996-05-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020338-001DIFFERIN0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD1996-05-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020338-001DIFFERIN0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD1996-05-31a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AdapaleneADAPALENEWalgreens2c1cdc03-087d-43b0-b0b3-503a35398a532026-08-21WarningsName fallback
generic name: ADAPALENE
AdapaleneADAPALENESafeway, Inc.a9816181-d643-4579-8b12-3927120dc6272026-06-18WarningsName fallback
generic name: ADAPALENE
AdapaleneADAPALENESun Pharmaceutical Industries, Inc.ca37576a-09aa-4ee8-9dc4-8ad76b999fcf2026-06-03Warnings, Adverse reactionsName fallback
generic name: ADAPALENE
ADAPALENEADAPALENERUGBY LABORATORIES, INC.330bc2b3-e064-4189-9c47-9c5a50aa4dde2026-06-01WarningsName fallback
generic name: ADAPALENE
AdapaleneADAPALENEBryant Ranch Prepack5f8189a2-a7ec-441b-993c-fed28b3ae24f2026-04-15Adverse reactionsName fallback
generic name: ADAPALENE
Neutrogena Evenly Clear Retinoid Adapalene Gel 0.1% Acne TreatmentADAPALENEKenvue Brands LLC4dfe533e-d3dc-b7ff-e063-6394a90ac61b2026-04-08WarningsName fallback
generic name: ADAPALENE
AdapaleneADAPALENEBryant Ranch Prepack79454b4c-3fd4-4e6d-b984-908f8cc8ab6d2026-04-07Adverse reactionsName fallback
generic name: ADAPALENE
AdapaleneADAPALENEThe Kroger Co.1238c72c-1c51-46e4-b15c-61093b03608e2026-03-23WarningsName fallback
generic name: ADAPALENE
AdapaleneADAPALENEYYBA Corp47d3a5f5-410c-288f-e063-6294a90a0d922026-02-03WarningsName fallback
generic name: ADAPALENE
AdapaleneADAPALENEGLENMARK THERAPEUTICS INC., USA42c1c354-2c00-4bc2-bbd3-a5dd5ff9a2082026-01-31WarningsName fallback
generic name: ADAPALENE
AdapaleneADAPALENEGLENMARK THERAPEUTICS INC., USAec6811f7-4728-41b1-8647-d63bb135e24e2026-01-31WarningsName fallback
generic name: ADAPALENE
AdapaleneADAPALENEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC276f7cce-5f54-40f8-8321-9192d0e52a732026-01-30Adverse reactionsName fallback
generic name: ADAPALENE
Curist Acne ReliefADAPALENELittle Pharma, Inc.e6380880-5299-0826-e053-2a95a90a19422026-01-11WarningsName fallback
generic name: ADAPALENE
Proactiv MD Adapalene Acne TreatmentADAPALENEAlchemee, LLC0a9b3755-c0db-4282-e063-6394a90a0c082026-01-07WarningsName fallback
generic name: ADAPALENE
EffaclarADAPALENELOreal USA Products Ince94854c5-6bb8-43db-b898-4d47a419d0752025-12-23WarningsName fallback
generic name: ADAPALENE
AdapaleneADAPALENEP & L Development, LLCe9155950-6c92-4f57-851a-51be6ba9062f2025-12-16WarningsName fallback
generic name: ADAPALENE
AdapaleneADAPALENEWal-Mart Stores Inc36eb4a78-3a7e-b39f-e063-6394a90ad1592025-12-16WarningsName fallback
generic name: ADAPALENE
AdapaleneADAPALENEWalgreens53087d52-3fef-4d28-b2ef-93470e3e19b52025-12-11WarningsName fallback
generic name: ADAPALENE
AdapaleneADAPALENEYYBA CORP44eb8cf6-d8ed-0e08-e063-6394a90ac8ef2025-12-01WarningsName fallback
generic name: ADAPALENE
AdapaleneADAPALENETopco Associates5693e3c9-00e5-4e62-b44a-47be2dc318112025-10-06WarningsName fallback
generic name: ADAPALENE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57645ORIG2019-02-15