Dalphene Index

Injectables — 26 products on the FDA record

Updated Jul 25 2026

34 of 136 products · 18 PMA · 7 BLA · 1 NDA · 8 No US authorization

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

Manufacturer14

Treatment areaderived

Evidenceper modality

EU registerpresence only

Narrows to products we matched in EUDAMED. There is no opposite filter.

34 products

Maker

No US authorization
DecisionStudies450Trials49

Maker

No US authorization
DecisionStudies2,396Trials79

Tiger Aesthetics Medical, LLC

PMA · approvedP020012
Approved2006StudiesTrials

Merz North America, Inc.

PMA · approvedP090016
Approved2011Studies1,298Trials46

Merz North America, Inc.

PMA · approvedP250016
Approved2026Studies1,298Trials46

Merz North America, Inc.

PMA · approvedP250020
Approved2026Studies1,298Trials46

ALLERGAN

BLA · approvedBLA103000
Approved1991Studies2,201Trials186

Maker

No US authorization
DecisionStudies158Trials106

REVANCE THERAPEUTICS, INC.

BLA · approvedBLA761127
Approved2022Studies2,201Trials186

IPSEN BIOPHARM LTD

BLA · approvedBLA125274
Approved2009Studies2,201Trials186

Maker

No US authorization
DecisionStudiesTrials

Maker

No US authorization
DecisionStudies158Trials106

HALOZYME THERAP

BLA · approvedBLA021859
Approved2005StudiesTrials

EVOLUS INC

BLA · approvedBLA761085
Approved2019Studies2,201Trials186

Maker

No US authorization
DecisionStudies158Trials106

Allergan

PMA · approvedP050047
Approved2010Studies1,298Trials46

Allergan

PMA · approvedP110033
Approved2016Studies1,298Trials46

Allergan

PMA · approvedP110033
Approved2017Studies1,298Trials46

Allergan

PMA · approvedP110033
Approved2013Studies1,298Trials46

Allergan

PMA · approvedP110033
Approved2022Studies1,298Trials46

ABBVIE

NDA · approvedNDA206333
Approved2015StudiesTrials

HUGEL INC

BLA · approvedBLA761225
Approved2024Studies2,201Trials186

Maker

No US authorization
DecisionStudies1,298Trials46

Merz North America, Inc.

PMA · approvedP050037
Approved2006Studies582Trials7

Maker

No US authorization
DecisionStudies155Trials16

Q-Med AB

PMA · approvedP140029EU
Approved2016Studies1,298Trials46

Q-Med AB

PMA · approvedP140029EU
Approved2020Studies1,298Trials46

Q-Med AB

PMA · approvedP040024EU
Approved2015Studies1,298Trials46

Q-Med AB

PMA · approvedP040024
Approved2014Studies1,298Trials46

Prollenium Medical Technologies, Inc.

PMA · approvedP160042
Approved2017Studies1,298Trials46

Teoxane S.A.

PMA · approvedP170002
Approved2017Studies1,298Trials46

Q-Med AB

PMA · approvedP030050EU
Approved2004Studies586Trials17

Allergan

PMA · approvedP110033
Approved2023Studies1,298Trials46

MERZ PHARMS

BLA · approvedBLA125360
Approved2010Studies2,201Trials186

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.

Comparisons in this category

Which pairs exist is editorial — observed search demand, not a judgement about any product.