Dalphene Index

Skin & Topicals — 9 products on the FDA record

Updated Jul 25 2026

10 of 136 products · 9 NDA · 1 No matched record

510(k) clearances per year

2015–2026 · 2026 partial

012015201720192021202320252026
510(k) clearances per year, Skin & Topicals device codes (2026 partial)
Skin & TopicalsTotal
201500
201600
201700
201800
201900
202000
202111
202200
202300
202400
202500
202600

510(k) clearance decisions per year in this category's device codes — filing activity, not sales or clinical benefit.

Filters

FDA pathwayCleared vs approvedCleared means the FDA agreed a device resembles one already on sale, while approved means the FDA read the maker's own clinical evidence and accepted it, so the two words describe different amounts of review and are not interchangeable.510(k) = cleared

Manufacturer7

Treatment areaderived

Evidenceper modality

10 products

GALDERMA LABS LP

NDA · approvedNDA211527
Approved2019Studies4,253Trials343

GALDERMA LABS LP

NDA · approvedNDA020380
Approved1996Studies4,253Trials343

Maker

Unverified mapping
DecisionStudies166Trials9

ABBVIE

NDA · approvedNDA022369
Approved2008Studies128Trials28

VALEANT PHARMS NORTH

NDA · approvedNDA021108
Approved2000Studies4,253Trials343

BAUSCH

NDA · approvedNDA017340
Approved1973Studies4,253Trials343

KENVUE BRANDS

NDA · approvedNDA019501
Approved1988StudiesTrials

ALMIRALL

NDA · approvedNDA020600
Approved1997Studies4,253Trials343

GALDERMA LABS LP

NDA · approvedNDA021112
Approved2002Studies1,116Trials51

SUN PHARM

NDA · approvedNDA213433
Approved2020Studies90Trials21

Curated seed list; study and trial counts are per modality, not per brand.

Sorted by most recent FDA decision — a filing date, not a quality signal.