fluocinolone acetonide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
steroids for topical use, acetal derivatives 1204 67-73-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fluocinolone acetonide
  • fluocinolonacetonid
  • fluocinolone acetonide dihydrate
  • fluocinolone acetonide oil
A glucocorticoid derivative used topically in the treatment of various skin disorders. It is usually employed as a cream, gel, lotion, or ointment. It has also been used topically in the treatment of inflammatory eye, ear, and nose disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p732)
  • Molecular weight: 452.50
  • Formula: C24H30F2O6
  • CLOGP: 2.25
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 2
  • TPSA: 93.06
  • ALOGS: -3.92
  • ROTB: 2
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BA (Bioavailability) 5 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 1.975 Moderate 0.69
caco2-efflux Caco-2 efflux ratio (BA/AB) 2.761 Moderate 0.69
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 42.170 10^-6 cm/s Moderate 0.69
dh-clint Dog hepatocyte intrinsic clearance 6.792 uL/min/10^6 cells Moderate 0.69
dppb Dog plasma protein binding (% unbound) 27.360 % Moderate 0.69
fcs-ppb Fetal calf serum protein binding (% unbound) 35.150 % Moderate 0.69
herg hERG pIC50 4.393 pIC50 Moderate 0.69
hh-clint Human hepatocyte intrinsic clearance 3.622 uL/min/10^6 cells Moderate 0.69
hlm-clint Human liver microsomal intrinsic clearance 12.735 uL/min/mg protein Moderate 0.69
hppb Human plasma protein binding (% unbound) 23.940 % Moderate 0.69
kinase-safety-class ACVR2B,CAMK2D,CDK5,EIF2AK3,GRK2,ITK,MAPK10,PDK1,PDK2,PDK4,PRKDC 11
kinase-selectivity-class GRK2 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 6.668 Moderate 0.69
mh-clint Mouse hepatocyte intrinsic clearance 15.776 Moderate 0.69
mppb Mouse plasma protein binding (% unbound) 28.520 Moderate 0.69
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 13.002 Moderate 0.69
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 32.570 % Moderate 0.69
rh-clint Rat hepatocyte intrinsic clearance 20.184 uL/min/10^6 cells Moderate 0.69
rh-fuinc Rat hepatocyte fraction unbound in incubation 73.540 % Moderate 0.69
rppb Rat plasma protein binding (% unbound) 20.340 % Moderate 0.69
solubility-dd Solubility at pH 7.4 in DMSO 616.595 uM Moderate 0.69

Approvals:

DateAgencyCompanyOrphan
Feb. 15, 1963 FDA MEDIMETRIKS PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Off label use 275.45 25.10 271 3310 1101981 89522885
Intraocular pressure increased 189.20 25.10 46 3535 7047 90617819
Circumstance or information capable of leading to medication error 162.50 25.10 38 3543 4929 90619937
Device failure 160.05 25.10 40 3541 6857 90618009
Medical device removal 123.06 25.10 24 3557 1309 90623557
Device dislocation 117.99 25.10 45 3536 31437 90593429
Drug delivery system issue 117.40 25.10 17 3564 142 90624724
Dermatitis atopic 115.50 25.10 41 3540 23431 90601435
Product dose omission issue 111.55 25.10 92 3489 291595 90333271
Hypotony of eye 111.28 25.10 17 3564 211 90624655
Psoriasis 90.77 25.10 62 3519 147692 90477174
Vitrectomy 88.08 25.10 14 3567 228 90624638
Corneal oedema 86.26 25.10 19 3562 1882 90622984
No adverse event 79.16 25.10 43 3538 67939 90556927
Needle issue 71.03 25.10 25 3556 13909 90610957
Implantation complication 62.29 25.10 8 3573 23 90624843
Pruritus 51.45 25.10 83 3498 541442 90083424
Product administration error 49.24 25.10 23 3558 26400 90598466
Vitreous haemorrhage 45.13 25.10 12 3569 2614 90622252
Ocular lymphoma 43.43 25.10 7 3574 125 90624741
Skin exfoliation 42.81 25.10 29 3552 67884 90556982
Dry skin 38.20 25.10 30 3551 88043 90536823
Drug delivery system malfunction 37.02 25.10 9 3572 1372 90623494
Eczema 36.75 25.10 24 3557 52846 90572020
Trabeculectomy 35.83 25.10 5 3576 31 90624835
Endophthalmitis 34.13 25.10 11 3570 4674 90620192
Skin discolouration 32.97 25.10 21 3560 44294 90580572
Skin plaque 32.86 25.10 13 3568 9962 90614904
Device dispensing error 27.49 25.10 5 3576 186 90624680
Glaucoma drainage device placement 27.42 25.10 3 3578 0 90624866
Drug dose omission by device 25.76 25.10 11 3570 10220 90614646
Sleep disorder due to a general medical condition 25.58 25.10 18 3563 44720 90580146
Patient uncooperative 25.51 25.10 5 3576 279 90624587
Corneal decompensation 25.41 25.10 4 3577 61 90624805

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Intraocular pressure increased 245.85 39.58 57 1841 6376 42613061
Device failure 227.51 39.58 46 1852 2697 42616740
Off label use 222.67 39.58 198 1700 638137 41981300
Circumstance or information capable of leading to medication error 219.23 39.58 44 1854 2484 42616953
Medical device removal 178.33 39.58 25 1873 141 42619296
Device dislocation 108.71 39.58 31 1867 7800 42611637
Drug delivery system issue 101.24 39.58 14 1884 70 42619367
No adverse event 97.16 39.58 43 1855 38978 42580459
Trabeculectomy 87.16 39.58 11 1887 22 42619415
Cataract operation 72.37 39.58 16 1882 1431 42618006
Glaucoma drainage device placement 72.17 39.58 8 1890 0 42619437
Dermatitis atopic 71.02 39.58 25 1873 12379 42607058
Vitrectomy 70.58 39.58 11 1887 138 42619299
Corneal oedema 65.87 39.58 15 1883 1533 42617904
Glaucoma 64.45 39.58 21 1877 8227 42611210
Needle issue 63.28 39.58 21 1877 8706 42610731
Macular oedema 53.43 39.58 15 1883 3554 42615883
Product dose omission issue 50.66 39.58 47 1851 154318 42465119
Trabeculoplasty 50.49 39.58 6 1892 5 42619432
Ocular hypertension 48.24 39.58 11 1887 1130 42618307
Implantation complication 45.81 39.58 6 1892 18 42619419
Hypotony of eye 44.36 39.58 8 1890 251 42619186

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Device failure 400.99 27.20 83 3707 7124 110578385
Circumstance or information capable of leading to medication error 396.85 27.20 78 3712 5155 110580354
Intraocular pressure increased 313.32 27.20 73 3717 10803 110574706
Medical device removal 266.25 27.20 42 3748 759 110584750
Drug delivery system issue 181.44 27.20 26 3764 235 110585274
Dermatitis atopic 153.46 27.20 50 3740 25491 110560018
Vitrectomy 148.61 27.20 22 3768 254 110585255
Device dislocation 146.71 27.20 51 3739 31653 110553856
No adverse event 142.54 27.20 63 3727 73776 110511733
Product dose omission issue 123.73 27.20 96 3694 321686 110263823
Needle issue 119.72 27.20 38 3752 17802 110567707
Hypotony of eye 108.21 27.20 18 3772 457 110585052
Corneal oedema 105.71 27.20 24 3766 3149 110582360
Trabeculectomy 99.56 27.20 13 3777 53 110585456
Glaucoma 80.70 27.20 30 3760 22487 110563022
Drug delivery system malfunction 75.77 27.20 15 3775 1020 110584489
Product administration error 75.76 27.20 33 3757 37184 110548325
Glaucoma drainage device placement 74.26 27.20 8 3782 0 110585509
Visual acuity reduced 60.54 27.20 27 3763 32146 110553363
Drug dose omission by device 58.15 27.20 21 3769 14495 110571014
Off label use 55.83 27.20 143 3647 1500042 109085467
Trabeculoplasty 55.69 27.20 6 3784 0 110585509
Cataract operation 54.22 27.20 16 3774 5867 110579642
Psoriasis 51.93 27.20 41 3749 139952 110445557
Macular oedema 51.55 27.20 16 3774 6950 110578559
Vitreous haemorrhage 48.93 27.20 14 3776 4606 110580903
Pruritus 48.81 27.20 78 3712 581482 110004027
Ocular hypertension 47.86 27.20 12 3778 2396 110583113
Retinal degeneration 46.94 27.20 11 3779 1655 110583854
Ciliary body operation 46.41 27.20 5 3785 0 110585509
Implantation complication 45.47 27.20 6 3784 27 110585482
Dry skin 45.32 27.20 34 3756 107619 110477890
Device dispensing error 40.57 27.20 7 3783 222 110585287
Sleep disorder due to a general medical condition 37.62 27.20 23 3767 52089 110533420
Endophthalmitis 37.17 27.20 13 3777 8174 110577335
Device difficult to use 36.07 27.20 16 3774 18789 110566720
Patient uncooperative 35.99 27.20 8 3782 952 110584557
Ocular lymphoma 34.17 27.20 6 3784 211 110585298
Eczema 33.04 27.20 24 3766 72269 110513240
Cystoid macular oedema 31.98 27.20 9 3781 2791 110582718
Corneal decompensation 31.96 27.20 5 3785 85 110585424
Eye pain 30.87 27.20 20 3770 50079 110535430

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C05AA10 CARDIOVASCULAR SYSTEM
VASOPROTECTIVES
AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
Corticosteroids
ATC D07AC04 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, potent (group III)
ATC D07BC02 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, COMBINATIONS WITH ANTISEPTICS
Corticosteroids, potent, combinations with antiseptics
ATC D07CC02 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS
Corticosteroids, potent, combinations with antibiotics
ATC S01BA15 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS
Corticosteroids, plain
ATC S01CA10 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
Corticosteroids and antiinfectives in combination
ATC S02BA08 SENSORY ORGANS
OTOLOGICALS
CORTICOSTEROIDS
Corticosteroids
ATC S02CA05 SENSORY ORGANS
OTOLOGICALS
CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION
Corticosteroids and antiinfectives in combination
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists
FDA EPC N0000175576 Corticosteroid
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D005938 Glucocorticoids
MeSH PA D006728 Hormones
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35472 anti-inflammatory drug
CHEBI has role CHEBI:39456 antiglaucoma drug
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:59683 antipruritic drug
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:67079 anti-inflammatory agent

Related Drugs by ATC class:

C05AA Corticosteroids 8 drugs
betamethasonedexamethasonefluocinonidefluocortolonefluorometholonehydrocortisoneprednisolonetriamcinolone
D07AC Corticosteroids, potent (group III) 20 drugs
amcinonidebeclometasone dipropionatebetamethasonebudesonidedesoximetasonediflorasone diacetatediflucortolonedifluprednatefluclorolonefludroxycortidefluocinonidefluocortolone show all 20 →
D07BC Corticosteroids, potent, combinations with antiseptics 3 drugs
betamethasonediflucortolonefluocortolone
D07CC Corticosteroids, potent, combinations with antibiotics 5 drugs
beclometasone dipropionatebetamethasonefludroxycortidefluocinonidefluocortolone
S01BA Corticosteroids, plain 15 drugs
alclometasone dipropionatebetamethasoneclobetasol propionateclobetasone butyratedesonidedexamethasonedifluprednatefluorometholoneformocortalhydrocortisoneloteprednol etabonatemedrysone show all 15 →
S01CA Corticosteroids and antiinfectives in combination 11 drugs
betamethasonechloroprednisoneclobetasone butyratedexamethasonefludrocortisone acetatefluocortolonefluorometholonehydrocortisoneloteprednol etabonatemethylprednisoloneprednisolone
S02BA Corticosteroids 4 drugs
betamethasonedexamethasonehydrocortisoneprednisolone
S02CA Corticosteroids and antiinfectives in combination 6 drugs
dexamethasonefludrocortisone acetateflumetasonehydrocortisoneprednisolonetriamcinolone

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Choroiditis indication 16553002 DOID:11406
Atopic dermatitis indication 24079001 DOID:3310
Chloasma indication 36209000
Contact dermatitis indication 40275004 DOID:2773
Seborrheic dermatitis indication 50563003 DOID:8741
Lichen simplex chronicus indication 53891004
Granuloma annulare indication 65508009 DOID:3777
Pruritus ani indication 90446007
Pityriasis simplex indication 200767005
Discoid lupus erythematosus indication 200938002
Plaque psoriasis indication 200965009
Scalp psoriasis indication 238608008
Pruritus of genital organs indication 267802000
Eruption of skin indication 271807003 DOID:0050486
Primary cutaneous T-cell lymphoma indication 400122007
Otitis Externa Eczema indication
Herpes simplex keratitis contraindication 9389005
Herpes zoster auricularis contraindication 21954000 DOID:9210
Sunburn contraindication 23346002
Glaucoma contraindication 23986001 DOID:1686
Fungal infection of eye contraindication 31194008
Herpes zoster keratoconjunctivitis contraindication 42448002
Eczema contraindication 43116000
Tuberculosis of eye contraindication 49107007
Herpes simplex keratoconjunctivitis contraindication 72321008
Third degree burn injury contraindication 80247002
Herpes simplex contraindication 88594005 DOID:8566
Open wound contraindication 125643001
Tuberculosis of ear contraindication 186269001
Telangiectasia disorder contraindication 247479008
Pregnancy, function contraindication 289908002
Viral ear infection contraindication 312137007
Fungal ear infection contraindication 312148000
Fungal keratitis contraindication 314558005
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Vaccinia keratitis contraindication 397552005
Herpes zoster keratitis contraindication 397573005
Atrophoderma contraindication 399979006
Peripheral vascular disease contraindication 400047006
Breastfeeding (mother) contraindication 413712001
Denuded skin contraindication 418242004




🐶 Veterinary Drug Use

SpeciesUseRelation
Cats Pruritus and inflammation associated with acute otitis externa Indication
Cats Pruritus and inflammation associated with acute and chronic dermatoses Indication
Dogs Pruritus and inflammation associated with superficial acute and chronic dermatoses Indication
Dogs Allergic and acute moist dermatoses Indication
Dogs Nonspecific dermatoses Indication
Dogs Wound infections Indication

🐶 Veterinary products

ProductApplicantIngredients
Neo-synalar Cream Bausch Health US LLC 2
Synalar Cream Veterinary Bausch Health US LLC 1
Synalar Solution Veterinary Bausch Health US LLC 1
Synotic Otic Solution Zoetis Inc. 2
Synsac Solution Zoetis Inc. 2

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.08 acidic
pKa2 11.78 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.18MG YUTIQ ALIMERA SCIENCES INC N210331 Oct. 12, 2018 RX IMPLANT INTRAVITREAL 7998108 Jan. 12, 2028 A METHOD OF INJECTING AN IMPLANT
0.19MG ILUVIEN ALIMERA SCIENCES INC N201923 Sept. 26, 2014 RX IMPLANT INTRAVITREAL 9849027 Nov. 7, 2028 THE TREATMENT OF DIABETIC MACULAR EDEMA (DME) IN PATIENTS WHO HAVE BEEN PREVIOUSLY TREATED WITH A COURSE OF CORTICOSTEROIDS AND DID HAVE A CLINICALLY SIGNIFICANT RISE IN INTRAOCULAR PRESSURE
0.19MG ILUVIEN ALIMERA SCIENCES INC N201923 Sept. 26, 2014 RX IMPLANT INTRAVITREAL 9849027 Nov. 7, 2028 TREATMENT OF CHRONIC NON-INFECTIOUS UVEITIS AFFECTING THE POSTERIOR SEGMENT OF THE EYE
EQ 0.3% BASE;0.025% OTOVEL LAB SALVAT N208251 April 29, 2016 RX SOLUTION/DROPS OTIC 8932610 March 24, 2030 TREATMENT OF ACUTE OTITIS MEDIA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST Ki 8.85 DRUG MATRIX CHEMBL
Progesterone receptor Transcription factor Ki 8.48 DRUG MATRIX

External reference:

IDSource
4018222 VUID
N0000146554 NUI
D01825 KEGG_DRUG
4018222 VANDF
4019759 VANDF
C0016298 UMLSCUI
CHEBI:31623 CHEBI
CHEMBL989 ChEMBL_ID
D005446 MESH_DESCRIPTOR_UI
DB00591 DRUGBANK_ID
7077 IUPHAR_LIGAND_ID
1046 INN_ID
0CD5FD6S2M UNII
6215 PUBCHEM_CID
DB12553 DRUGBANK_ID
25126 RXNORM
4738 MMSL
002193 NDDF
011117 NDDF
28426008 SNOMEDCT_US
395977002 SNOMEDCT_US
396059004 SNOMEDCT_US
C0060507 UMLSCUI
CHEMBL1201390 ChEMBL_ID
807-38-5 SECONDARY_CAS_RN
91488 PUBCHEM_CID
C035394 MESH_SUPPLEMENTAL_RECORD_UI
CT1IX58L9S UNII
CHEBI:5108 CHEBI
0CD5FD6S2M INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Fluocinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0168-0059 SOLUTION 0.10 mg TOPICAL ANDA 18 sections
Fluocinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0168-0064 OINTMENT 0.25 mg TOPICAL ANDA 18 sections
TRI-LUMA HUMAN PRESCRIPTION DRUG LABEL 3 0299-5950 CREAM 0.10 mg TOPICAL NDA 24 sections
Fluocinolone Acetonide Topical HUMAN PRESCRIPTION DRUG LABEL 1 0591-2990 SOLUTION 0.10 mg TOPICAL ANDA 17 sections
Fluocinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0713-0222 CREAM 0.25 mg TOPICAL ANDA 10 sections
Fluocinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0713-0223 CREAM 0.10 mg TOPICAL ANDA 10 sections
Fluocinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0713-0224 OINTMENT 0.25 mg TOPICAL ANDA 10 sections
FLUOCINOLONE ACETONIDE HUMAN PRESCRIPTION DRUG LABEL 1 0713-0709 CREAM 0.25 mg TOPICAL ANDA 11 sections
fluocinolone acetonide HUMAN PRESCRIPTION DRUG LABEL 1 10135-670 SOLUTION 0.10 mg TOPICAL ANDA 18 sections
Fluocinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 16590-097 CREAM 0.10 mg TOPICAL ANDA 11 sections
Fluocinolone Acetonide Topical Solution USP, 0.01% HUMAN PRESCRIPTION DRUG LABEL 1 21922-003 SOLUTION 0.10 mg TOPICAL ANDA 17 sections
Retisert HUMAN PRESCRIPTION DRUG LABEL 1 24208-416 IMPLANT 0.59 mg INTRAVITREAL NDA 22 sections
OTOVEL HUMAN PRESCRIPTION DRUG LABEL 2 24338-080 SOLUTION 0.06 mg AURICULAR (OTIC) NDA 26 sections
Flac Otic Oil HUMAN PRESCRIPTION DRUG LABEL 1 39328-079 OIL 0.11 mg AURICULAR (OTIC) ANDA 22 sections
Ciprofloxacin and Fluocinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 2 42195-128 SOLUTION 0.06 mg AURICULAR (OTIC) NDA authorized generic 26 sections
Fluocinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 43386-069 SOLUTION 0.10 mg TOPICAL ANDA 15 sections
Synalar HUMAN PRESCRIPTION DRUG LABEL 1 43538-900 CREAM 0.25 mg TOPICAL NDA 21 sections
Synalar HUMAN PRESCRIPTION DRUG LABEL 1 43538-910 OINTMENT 0.25 mg TOPICAL NDA 19 sections
Neo-Synalar HUMAN PRESCRIPTION DRUG LABEL 2 43538-940 CREAM 0.25 mg TOPICAL ANDA 20 sections
Fluocinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 45802-009 OIL 0.11 mg AURICULAR (OTIC) ANDA 22 sections
Fluocinolone acetonide HUMAN PRESCRIPTION DRUG LABEL 1 45802-485 OIL 0.01 mg TOPICAL ANDA 22 sections
fluocinolone acetonide HUMAN PRESCRIPTION DRUG LABEL 1 45802-887 OIL 0.01 mg TOPICAL ANDA 21 sections
Fluocinolone AcetonideOil HUMAN PRESCRIPTION DRUG LABEL 1 50090-6780 OIL 0.11 mg TOPICAL ANDA 20 sections
Fluocinolone acetonide HUMAN PRESCRIPTION DRUG LABEL 1 50090-7958 OIL 0.01 mg TOPICAL ANDA 22 sections
Fluocinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 51672-1356 OIL 0.11 mg TOPICAL ANDA 25 sections
Fluocinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 51672-1357 OIL 0.11 mg TOPICAL ANDA 21 sections
Fluocinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 51672-1365 SOLUTION 0.10 mg TOPICAL ANDA 20 sections
Fluocinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 52565-012 SOLUTION 0.10 mg TOPICAL NDA AUTHORIZED GENERIC 20 sections
Fluocinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 52565-013 OINTMENT 0.25 mg TOPICAL NDA AUTHORIZED GENERIC 20 sections
Fluocinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 52565-020 CREAM 0.25 mg TOPICAL NDA AUTHORIZED GENERIC 20 sections