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Active ingredient

Fluocinolone

49 finished FDA listings contain Fluocinolone as their only active ingredient; 2 combination products also contain it.

FDA NDC Directory

Ingredient names as written by FDA
FLUOCINOLONE ACETONIDE
Dosage forms
Cream, Implant, Oil, Ointment, Solution
Routes
Auricular (Otic), Intravitreal, Topical
Manufacturers / labelers
21
Strengths listed
.01 mg/100ml · .1 mg/g · .1 mg/ml · .11 mg/118.28ml · .11 mg/ml · .18 mg/1 · .19 mg/1 · .25 mg/g · .59 mg/1
Brand names in FDA listings
Derma-Smoothe/Fs, Dermotic, Flac Otic Oil, Fluocinolone Acetonide Oil, Iluvien, Retisert, Synalar, Yutiq

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 25126

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 012787EUROFARMA1963-02-153
NDA 013960EUROFARMA1963-06-192
ANDA 088167FOUGERA PHARMS INC1982-12-161
ANDA 088168FOUGERA PHARMS INC1982-12-161
ANDA 089124SUN PHARMA CANADA1985-09-111
NDA 019452HILL DERMAC1988-02-033
ANDA 089524COSETTE PHARMS NC1988-07-261
ANDA 089526COSETTE PHARMS NC1988-07-261
NDA 021737BAUSCH AND LOMB2005-04-081
ANDA 201759AMNEAL2011-10-171
ANDA 202848PADAGIS ISRAEL2013-08-094
ANDA 202847PADAGIS ISRAEL2013-08-093
NDA 201923ALIMERA SCIENCES INC2014-09-261
ANDA 206422LUPIN2015-09-021
ANDA 090982RISING2016-04-252
ANDA 203377RISING2016-04-251
ANDA 203378RISING2016-04-251
ANDA 202368SUN PHARMA CANADA2016-05-191
ANDA 209336SUN PHARMA CANADA2016-05-191
ANDA 208386ACTAVIS LABS UT INC2016-10-211
ANDA 202849PADAGIS ISRAEL2017-07-171
ANDA 210736ANDA REPOSITORY2018-04-111
NDA 210331ALIMERA SCIENCES INC2018-10-121
ANDA 210539GLENMARK PHARMS LTD2018-10-261
ANDA 210747COSETTE PHARMS NC2018-11-051
ANDA 211815GLENMARK PHARMS LTD2018-12-141
ANDA 209913ENCUBE ETHICALS2019-02-133
ANDA 212762QUAGEN2021-04-023
ANDA 212761QUAGEN2021-04-023
ANDA 212760QUAGEN2021-04-023

Official labeling on DailyMed

Showing the 12 most recent of 46 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.