acitretin ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
retinol derivatives 78 55079-83-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • acitretin
  • acitretinoin
  • etretin
  • neotigason
  • soriatane
  • isoacitretin
  • isoetretin
An oral retinoid effective in the treatment of psoriasis. It is the major metabolite of ETRETINATE with the advantage of a much shorter half-life when compared with etretinate.
  • Molecular weight: 326.44
  • Formula: C21H26O3
  • CLOGP: 6.07
  • LIPINSKI: 1
  • HAC: 3
  • HDO: 1
  • TPSA: 46.53
  • ALOGS: -5.83
  • ROTB: 6

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
35 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 3.83 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 59 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Oct. 28, 1996 FDA STIEFEL LABS INC

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
Psoriasis 813.23 21.00 332 7821 68668 50528303
Skin haemorrhage 180.48 21.00 60 8093 6858 50590113
Skin exfoliation 138.49 21.00 79 8074 33533 50563438
Psoriatic arthropathy 109.41 21.00 77 8076 46955 50550016
Neurologic neglect syndrome 82.70 21.00 23 8130 1435 50595536
Respiratory tract congestion 82.61 21.00 42 8111 14157 50582814
Carotid artery thrombosis 82.07 21.00 23 8130 1476 50595495
Sinus congestion 71.73 21.00 38 8115 13933 50583038
Sneezing 71.54 21.00 38 8115 14006 50582965
Cutaneous T-cell lymphoma 62.90 21.00 18 8135 1246 50595725
Adjustment disorder 62.73 21.00 20 8133 1999 50594972
Sinus disorder 61.86 21.00 38 8115 18420 50578551
Drug ineffective 60.88 21.00 276 7877 819057 49777914
Personality disorder 58.16 21.00 23 8130 4301 50592670
Rhinorrhoea 57.38 21.00 55 8098 51528 50545443
Skin plaque 56.04 21.00 25 8128 6303 50590668
Infected dermal cyst 54.43 21.00 13 8140 441 50596530
Rash pustular 52.31 21.00 24 8129 6457 50590514
Rhesus antigen positive 51.41 21.00 10 8143 124 50596847
Pruritus 51.02 21.00 129 8024 283439 50313532
Skin lesion 49.12 21.00 38 8115 26689 50570282
Erythema 49.08 21.00 86 8067 146328 50450643
Sensory loss 48.26 21.00 24 8129 7714 50589257
Oral lichen planus 47.26 21.00 12 8141 526 50596445
Hemiplegia 46.35 21.00 23 8130 7358 50589613
Dry skin 46.05 21.00 45 8108 43146 50553825
Affect lability 44.84 21.00 24 8129 8974 50587997
Motor dysfunction 44.51 21.00 23 8130 8008 50588963
Erythrodermic psoriasis 40.87 21.00 12 8141 909 50596062
Wrong technique in device usage process 39.76 21.00 15 8138 2471 50594500
Weaning failure 37.46 21.00 9 8144 313 50596658
Coordination abnormal 36.75 21.00 23 8130 11511 50585460
Guttate psoriasis 36.32 21.00 9 8144 357 50596614
Burning sensation 35.31 21.00 40 8113 45406 50551565
Skin fissures 34.65 21.00 20 8133 8648 50588323
Blood immunoglobulin M decreased 34.65 21.00 10 8143 713 50596258
Squamous cell carcinoma 34.02 21.00 19 8134 7720 50589251
Influenza 33.14 21.00 55 8098 89483 50507488
Blood albumin increased 32.77 21.00 10 8143 865 50596106
Lichen planus 31.86 21.00 12 8141 1967 50595004
Immunoglobulins decreased 31.35 21.00 10 8143 1000 50595971
Cystitis 30.90 21.00 37 8116 44527 50552444
Eating disorder 30.71 21.00 23 8130 15386 50581585
Muscle spasticity 30.63 21.00 24 8129 17160 50579811
Type IIb hyperlipidaemia 28.95 21.00 5 8148 30 50596941
Inflammatory bowel disease 28.54 21.00 13 8140 3437 50593534
Oesophageal stenosis 27.59 21.00 12 8141 2846 50594125
Hemiparesis 27.39 21.00 24 8129 20024 50576947
Increased bronchial secretion 27.08 21.00 10 8143 1552 50595419
Pustular psoriasis 26.77 21.00 13 8140 3968 50593003
Tongue ulceration 26.73 21.00 12 8141 3068 50593903
Inappropriate schedule of product administration 26.40 21.00 44 8109 71787 50525184
Injection site bruising 26.27 21.00 31 8122 36737 50560234
Sunburn 26.21 21.00 11 8142 2392 50594579
Face oedema 25.67 21.00 22 8131 17817 50579154
Onychalgia 25.21 21.00 8 8145 787 50596184
Influenza like illness 24.97 21.00 38 8115 57421 50539550
Blood immunoglobulin G decreased 24.75 21.00 10 8143 1975 50594996
Tanning 24.70 21.00 5 8148 77 50596894
Toxicity to various agents 23.99 21.00 3 8150 212496 50384475
Oesophageal ulcer 23.90 21.00 12 8141 3933 50593038
Skin infection 23.73 21.00 18 8135 12273 50584698
Mean cell haemoglobin increased 23.67 21.00 10 8143 2210 50594761
Skin atrophy 23.07 21.00 12 8141 4233 50592738
Pregnancy of partner 22.38 21.00 4 8149 30 50596941
Retroperitoneal abscess 22.21 21.00 5 8148 130 50596841
Aphasia 21.99 21.00 25 8128 28469 50568502
Plantar fasciitis 21.04 21.00 10 8143 2911 50594060
Rickets 21.00 21.00 4 8149 44 50596927

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
Psoriasis 703.90 22.35 253 5283 31974 29537017
Vein rupture 195.27 22.35 41 5495 652 29568339
Drug ineffective 187.05 22.35 279 5257 362891 29206100
Skin plaque 164.06 22.35 50 5486 3712 29565279
Venous injury 110.50 22.35 22 5514 264 29568727
Injection site haemorrhage 104.40 22.35 44 5492 8342 29560649
Injection site papule 85.30 22.35 18 5518 293 29568698
Erythrodermic psoriasis 83.00 22.35 21 5515 779 29568212
Dermatitis exfoliative generalised 82.87 22.35 28 5508 2888 29566103
Injection site swelling 80.57 22.35 38 5498 9379 29559612
Inappropriate schedule of product administration 79.28 22.35 66 5470 44406 29524585
Cutaneous T-cell lymphoma 77.50 22.35 22 5514 1271 29567720
Squamous cell carcinoma 60.05 22.35 32 5504 10219 29558772
Psoriatic arthropathy 59.44 22.35 36 5500 14655 29554336
Skin erosion 58.66 22.35 19 5517 1717 29567274
Hypercholesterolaemia 55.20 22.35 27 5509 7211 29561780
Granuloma annulare 55.01 22.35 11 5525 135 29568856
Squamous cell carcinoma of skin 51.06 22.35 28 5508 9458 29559533
Pain in extremity 47.90 22.35 79 5457 110354 29458637
Phototherapy 47.81 22.35 8 5528 32 29568959
Pain of skin 47.40 22.35 20 5516 3795 29565196
Myalgia 44.97 22.35 62 5474 73957 29495034
Therapeutic product effect incomplete 43.98 22.35 45 5491 39260 29529731
Pruritus 43.33 22.35 78 5458 116771 29452220
Muscular weakness 40.76 22.35 54 5482 61998 29506993
Keratoacanthoma 40.17 22.35 11 5525 556 29568435
Basal cell carcinoma 38.46 22.35 29 5507 16881 29552110
Pityriasis rubra pilaris 37.39 22.35 7 5529 59 29568932
Induration 35.44 22.35 11 5525 865 29568126
Malignant melanoma stage I 35.00 22.35 7 5529 86 29568905
Skin exfoliation 34.98 22.35 31 5505 22614 29546377
Botryomycosis 34.13 22.35 6 5530 34 29568957
Macule 33.84 22.35 11 5525 1005 29567986
Insomnia 33.83 22.35 60 5476 88701 29480290
Hyperkeratosis 33.62 22.35 15 5521 3254 29565737
Neuroendocrine tumour of the lung metastatic 33.52 22.35 7 5529 108 29568883
Retinal disorder 31.01 22.35 10 5526 890 29568101
Myasthenia gravis 30.94 22.35 14 5522 3137 29565854
Decreased immune responsiveness 30.09 22.35 11 5525 1428 29567563
Skin injury 28.83 22.35 10 5526 1114 29567877
Drug intolerance 28.56 22.35 40 5496 48339 29520652
Erythema 27.38 22.35 50 5486 75556 29493435
Type 2 diabetes mellitus 25.91 22.35 21 5515 13560 29555431
Gastrointestinal tube insertion 24.98 22.35 9 5527 1120 29567871
Hepatic cirrhosis 24.78 22.35 21 5515 14423 29554568
Hidradenitis 24.64 22.35 8 5528 728 29568263
Hypereosinophilic syndrome 24.24 22.35 6 5530 203 29568788
Skin lesion 23.97 22.35 23 5513 18549 29550442
Emotional distress 23.43 22.35 20 5516 13875 29555116
Angioplasty 22.71 22.35 8 5528 933 29568058
Cutaneous symptom 22.63 22.35 6 5530 268 29568723
Toxicity to various agents 22.44 22.35 3 5533 173658 29395333

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
Psoriasis 1283.92 19.20 492 12063 71211 64414966
Drug ineffective 209.95 19.20 485 12070 839762 63646415
Skin haemorrhage 182.15 19.20 67 12488 8518 64477659
Skin plaque 161.42 19.20 62 12493 8878 64477299
Vein rupture 160.94 19.20 41 12514 1502 64484675
Skin exfoliation 140.73 19.20 95 12460 44790 64441387
Cutaneous T-cell lymphoma 126.02 19.20 37 12518 2315 64483862
Psoriatic arthropathy 113.24 19.20 82 12473 43199 64442978
Squamous cell carcinoma 98.73 19.20 50 12505 13819 64472358
Inappropriate schedule of product administration 95.13 19.20 103 12452 92183 64393994
Injection site haemorrhage 94.79 19.20 59 12496 24219 64461958
Erythrodermic psoriasis 94.18 19.20 27 12528 1552 64484625
Venous injury 93.31 19.20 22 12533 580 64485597
Dermatitis exfoliative generalised 89.13 19.20 36 12519 5880 64480297
Pruritus 78.92 19.20 182 12373 312218 64173959
Neurologic neglect syndrome 76.03 19.20 23 12532 1595 64484582
Carotid artery thrombosis 73.67 19.20 23 12532 1772 64484405
Skin lesion 71.01 19.20 58 12497 36424 64449753
Respiratory tract congestion 70.04 19.20 42 12513 16123 64470054
Injection site papule 66.93 19.20 18 12537 816 64485361
Sneezing 61.90 19.20 38 12517 15213 64470964
Sinus congestion 61.47 19.20 38 12517 15401 64470776
Sinus disorder 60.76 19.20 39 12516 16869 64469308
Erythema 56.24 19.20 117 12438 186953 64299224
Keratoacanthoma 56.04 19.20 16 12539 906 64485271
Toxicity to various agents 55.45 19.20 4 12551 363509 64122668
Adjustment disorder 53.00 19.20 20 12535 2725 64483452
Personality disorder 52.05 19.20 23 12532 4688 64481489
Rhinorrhoea 49.99 19.20 60 12495 59909 64426268
Rhesus antigen positive 49.52 19.20 10 12545 124 64486053
Skin erosion 46.32 19.20 20 12535 3856 64482321
Therapeutic product effect incomplete 45.19 19.20 76 12479 103406 64382771
Pain of skin 44.48 19.20 26 12529 9521 64476656
Squamous cell carcinoma of skin 44.18 19.20 28 12527 11848 64474329
Pityriasis rubra pilaris 42.15 19.20 8 12547 70 64486107
Pain in extremity 42.00 19.20 142 12413 302943 64183234
Phototherapy 41.55 19.20 7 12548 28 64486149
Hyperkeratosis 41.54 19.20 22 12533 6659 64479518
Affect lability 40.61 19.20 24 12531 8966 64477211
Infected dermal cyst 40.42 19.20 12 12543 780 64485397
Sensory loss 40.40 19.20 25 12530 10144 64476033
Onychalgia 40.34 19.20 12 12543 785 64485392
Granuloma annulare 40.31 19.20 11 12544 527 64485650
Skin fissures 40.09 19.20 25 12530 10281 64475896
Pustular psoriasis 38.55 19.20 18 12537 4165 64482012
Myalgia 38.38 19.20 91 12464 158526 64327651
Oral lichen planus 37.74 19.20 11 12544 670 64485507
Hypercholesterolaemia 37.63 19.20 28 12527 15345 64470832
Dry skin 37.51 19.20 48 12507 51113 64435064
Injection site swelling 37.15 19.20 43 12512 41310 64444867
Muscular weakness 36.32 19.20 78 12477 127260 64358917
Rash pustular 36.01 19.20 23 12532 9862 64476315
Motor dysfunction 35.43 19.20 24 12531 11349 64474828
Induration 35.33 19.20 13 12542 1651 64484526
Guttate psoriasis 33.81 19.20 9 12546 392 64485785
Influenza 33.58 19.20 68 12487 106463 64379714
Neuroendocrine tumour of the lung metastatic 33.18 19.20 7 12548 109 64486068
Malignant melanoma stage I 32.44 19.20 7 12548 122 64486055
Dyslipidaemia 32.42 19.20 21 12534 9221 64476956
Wrong technique in device usage process 31.61 19.20 14 12541 2868 64483309
Hemiplegia 30.68 19.20 23 12532 12745 64473432
Immunoglobulins decreased 30.60 19.20 11 12544 1307 64484870
Macule 30.58 19.20 13 12542 2413 64483764
Acute kidney injury 30.06 19.20 26 12529 449214 64036963
Weaning failure 29.84 19.20 9 12546 617 64485560
Blood immunoglobulin M decreased 29.75 19.20 10 12545 974 64485203
Cystitis 28.12 19.20 38 12517 42637 64443540
Type IIb hyperlipidaemia 28 19.20 5 12550 30 64486147
Coordination abnormal 27.46 19.20 23 12532 14941 64471236
Muscle spasticity 27.29 19.20 24 12531 16645 64469532
Skin atrophy 27.24 19.20 15 12540 4905 64481272
Skin disorder 26.92 19.20 30 12525 27650 64458527
Burning sensation 26.51 19.20 40 12515 49624 64436553
Blood albumin increased 26.51 19.20 10 12545 1361 64484816
Inflammatory bowel disease 25.57 19.20 14 12541 4524 64481653
Rebound psoriasis 25.45 19.20 6 12549 158 64486019
Eating disorder 25.15 19.20 23 12532 16782 64469395
Insomnia 25.02 19.20 90 12465 197746 64288431
Botryomycosis 24.99 19.20 5 12550 59 64486118
Neutropenia 24.60 19.20 8 12547 239616 64246561
Lichen planus 24.54 19.20 11 12544 2317 64483860
Cutaneous symptom 23.91 19.20 7 12548 433 64485744
Tanning 23.88 19.20 5 12550 75 64486102
Death 23.56 19.20 36 12519 482669 64003508
Hypotension 23.18 19.20 24 12531 380950 64105227
Basal cell carcinoma 22.70 19.20 29 12526 30809 64455368
Psoriasis area severity index increased 22.33 19.20 5 12550 104 64486073
Nasopharyngitis 22.12 19.20 86 12469 195987 64290190
Arthritis 21.25 19.20 49 12506 83765 64402412
Sunburn 20.79 19.20 11 12544 3321 64482856
Cellulitis 20.78 19.20 52 12503 93605 64392572
Somnolence 20.55 19.20 7 12548 203638 64282539
Injection site bruising 20.42 19.20 30 12525 36343 64449834
Diffuse idiopathic skeletal hyperostosis 20.42 19.20 4 12551 42 64486135
Blood immunoglobulin G decreased 20.05 19.20 10 12545 2673 64483504
Myasthenia gravis 20.03 19.20 13 12542 5725 64480452
Tongue ulceration 19.92 19.20 11 12544 3615 64482562
Anaemia 19.68 19.20 27 12528 378653 64107524
Plantar fasciitis 19.58 19.20 10 12545 2810 64483367
Increased bronchial secretion 19.50 19.20 10 12545 2832 64483345
Skin infection 19.48 19.20 19 12536 15018 64471159
Oesophageal stenosis 19.35 19.20 11 12544 3823 64482354
Dehydration 19.33 19.20 9 12546 216754 64269423

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D05BB02 DERMATOLOGICALS
ANTIPSORIATICS
ANTIPSORIATICS FOR SYSTEMIC USE
Retinoids for treatment of psoriasis
FDA CS M0018962 Retinoids
FDA EPC N0000175607 Retinoid
CHEBI has role CHEBI:50176 keratolytic drugs
MeSH PA D003879 Dermatologic Agents
MeSH PA D007641 Keratolytic Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Severe Recalcitrant Psoriasis indication
Lichen planus off-label use 4776004 DOID:9201
Keratosis follicularis off-label use 48611009 DOID:2734
Lamellar ichthyosis off-label use 205550003
Ichthyosiform erythroderma off-label use 268282005
Primary cutaneous T-cell lymphoma off-label use 400122007
Alcoholism contraindication 7200002
Hypercholesterolemia contraindication 13644009
Depressive disorder contraindication 35489007
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Night blindness contraindication 65194006 DOID:8499
Benign intracranial hypertension contraindication 68267002 DOID:11459
Diabetes mellitus contraindication 73211009 DOID:9351
Premature epiphyseal closure contraindication 89493005
Liver function tests abnormal contraindication 166603001
Hypoalphalipoproteinemia contraindication 190785000
Acute pancreatitis contraindication 197456007 DOID:2913
Hypertrophy of bone contraindication 203514008 DOID:205
Drug-induced hepatitis contraindication 235876009
Pregnancy, function contraindication 289908002
Hypertriglyceridemia contraindication 302870006
Cardiovascular event risk contraindication 395112001
Visual impairment contraindication 397540003
Breastfeeding (mother) contraindication 413712001
Obesity contraindication 414916001 DOID:9970
Psychiatric Disturbance contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.17 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Retinoic acid receptor alpha Nuclear hormone receptor AGONIST WOMBAT-PK CHEMBL
Retinoic acid receptor gamma Nuclear hormone receptor AGONIST CHEMBL CHEMBL
Bile salt export pump Transporter IC50 4.74 CHEMBL
Bile salt export pump Transporter IC50 4.71 CHEMBL

External reference:

IDSource
4021061 VUID
N0000148524 NUI
D02754 KEGG_DRUG
16818 RXNORM
C0050559 UMLSCUI
CHEBI:50173 CHEBI
CHEMBL1131 ChEMBL_ID
DB00459 DRUGBANK_ID
D017255 MESH_DESCRIPTOR_UI
5284513 PUBCHEM_CID
7598 IUPHAR_LIGAND_ID
5530 INN_ID
69427-46-9 SECONDARY_CAS_RN
LCH760E9T7 UNII
11379 MMSL
117161 MMSL
4128 MMSL
d03836 MMSL
004121 NDDF
4021061 VANDF
108914001 SNOMEDCT_US
386938006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Acitretin HUMAN PRESCRIPTION DRUG LABEL 1 0093-1135 CAPSULE 10 mg ORAL ANDA 24 sections
Acitretin HUMAN PRESCRIPTION DRUG LABEL 1 0093-1135 CAPSULE 10 mg ORAL ANDA 24 sections
Acitretin HUMAN PRESCRIPTION DRUG LABEL 1 0093-1136 CAPSULE 25 mg ORAL ANDA 24 sections
Acitretin HUMAN PRESCRIPTION DRUG LABEL 1 0093-1136 CAPSULE 25 mg ORAL ANDA 24 sections
Acitretin HUMAN PRESCRIPTION DRUG LABEL 1 0093-1138 CAPSULE 17.50 mg ORAL ANDA 24 sections
Acitretin HUMAN PRESCRIPTION DRUG LABEL 1 0093-1138 CAPSULE 17.50 mg ORAL ANDA 24 sections
Acitretin HUMAN PRESCRIPTION DRUG LABEL 1 0115-1750 CAPSULE 10 mg ORAL ANDA 17 sections
Acitretin HUMAN PRESCRIPTION DRUG LABEL 1 0115-1751 CAPSULE 17.50 mg ORAL ANDA 17 sections
Acitretin HUMAN PRESCRIPTION DRUG LABEL 1 0115-1752 CAPSULE 22.50 mg ORAL ANDA 17 sections
Acitretin HUMAN PRESCRIPTION DRUG LABEL 1 0115-1753 CAPSULE 25 mg ORAL ANDA 17 sections
SORIATANE HUMAN PRESCRIPTION DRUG LABEL 1 0145-0090 CAPSULE 10 mg ORAL NDA 27 sections
SORIATANE HUMAN PRESCRIPTION DRUG LABEL 1 0145-0091 CAPSULE 25 mg ORAL NDA 27 sections
Acitretin HUMAN PRESCRIPTION DRUG LABEL 1 0378-7020 CAPSULE 10 mg ORAL ANDA 28 sections
Acitretin HUMAN PRESCRIPTION DRUG LABEL 1 0378-7023 CAPSULE 25 mg ORAL ANDA 28 sections
ACITRETIN HUMAN PRESCRIPTION DRUG LABEL 1 42291-086 CAPSULE 10 mg ORAL ANDA 25 sections
ACITRETIN HUMAN PRESCRIPTION DRUG LABEL 1 42291-087 CAPSULE 17.50 mg ORAL ANDA 25 sections
ACITRETIN HUMAN PRESCRIPTION DRUG LABEL 1 42291-088 CAPSULE 25 mg ORAL ANDA 25 sections
ACITRETIN HUMAN PRESCRIPTION DRUG LABEL 1 42794-080 CAPSULE 10 mg ORAL ANDA 25 sections
ACITRETIN HUMAN PRESCRIPTION DRUG LABEL 1 42794-081 CAPSULE 17.50 mg ORAL ANDA 25 sections
ACITRETIN HUMAN PRESCRIPTION DRUG LABEL 1 42794-083 CAPSULE 25 mg ORAL ANDA 25 sections
ACITRETIN HUMAN PRESCRIPTION DRUG LABEL 1 66993-894 CAPSULE 10 mg ORAL NDA authorized generic 16 sections
ACITRETIN HUMAN PRESCRIPTION DRUG LABEL 1 66993-896 CAPSULE 25 mg ORAL NDA authorized generic 16 sections