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

Stem definitionDrug idCAS RN
prednisone and prednisolone derivatives 4452 25122-46-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • clobetasol 17-propionate
  • clofenazon
  • clobetasol propionate
A derivative of PREDNISOLONE with high glucocorticoid activity and low mineralocorticoid activity. Absorbed through the skin faster than FLUOCINONIDE, it is used topically in treatment of PSORIASIS but may cause marked adrenocortical suppression.
  • Molecular weight: 466.97
  • Formula: C25H32ClFO5
  • CLOGP: 3.49
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 80.67
  • ALOGS: -5.05
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

None

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.11 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Dec. 27, 1985 FDA FOUGERA PHARMS
Feb. 24, 2021 PMDA Maruho Co., Ltd.

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 215.64 12.97 152 10818 86805 63391247
Skin atrophy 154.82 12.97 50 10920 4856 63473196
Squamous cell carcinoma of skin 147.75 12.97 51 10919 6081 63471971
Skin exfoliation 124.82 12.97 83 10887 43019 63435033
Dry skin 89.48 12.97 76 10894 56811 63421241
Dermatitis atopic 82.25 12.97 38 10932 9686 63468366
Pruritus 75.78 12.97 182 10788 361271 63116781
Eczema 69.75 12.97 52 10918 32239 63445813
Product use in unapproved indication 68.56 12.97 116 10854 178964 63299088
Skin fissures 64.90 12.97 34 10936 11354 63466698
Cushing's syndrome 52.91 12.97 14 10956 673 63477379
Neoplasm skin 49.61 12.97 16 10954 1545 63476507
Delayed myelination 45.98 12.97 6 10964 0 63478052
Skin haemorrhage 43.34 12.97 25 10945 10069 63467983
Product dose omission issue 36.71 12.97 106 10864 234207 63243845
Steroid diabetes 35.90 12.97 12 10958 1296 63476756
Biliary sepsis 35.64 12.97 11 10959 920 63477132
Skin plaque 34.11 12.97 20 10950 8300 63469752
Ochronosis 33.64 12.97 6 10964 41 63478011
Erythema 29.94 12.97 82 10888 175669 63302383
Injection site alopecia 29.04 12.97 5 10965 27 63478025
Cushingoid 28.62 12.97 18 10952 8467 63469585
Contraindicated product administered 27.08 12.97 3 10967 217645 63260407
Skin burning sensation 26.36 12.97 20 10950 12714 63465338
Dermatitis bullous 26.10 12.97 17 10953 8491 63469561
Injection site pain 25.62 12.97 64 10906 129736 63348316
Resting tremor 24.39 12.97 8 10962 815 63477237
Psoriatic arthropathy 23.43 12.97 50 10920 91470 63386582
Dermatitis 23.30 12.97 21 10949 16937 63461115
Infusion related reaction 22.87 12.97 7 10963 245514 63232538
Alopecia scarring 22.66 12.97 5 10965 110 63477942
Synovitis 22.21 12.97 3 10967 186915 63291137
Drug intolerance 22.06 12.97 13 10957 308648 63169404
Product container issue 21.64 12.97 9 10961 1784 63476268
Bronchiolitis obliterans syndrome 21.61 12.97 5 10965 137 63477915
Pain of skin 21.32 12.97 17 10953 11617 63466435
Skin striae 20.23 12.97 8 10962 1393 63476659
Necrotising fasciitis 19.99 12.97 10 10960 3031 63475021
Pemphigus 19.50 12.97 4 10966 183722 63294330
Systemic lupus erythematosus 19.37 12.97 6 10964 208912 63269140
Papule 19.01 12.97 12 10958 5679 63472373
Glossodynia 18.76 12.97 4 10966 178872 63299180
Toxicity to various agents 18.25 12.97 10 10960 247240 63230812
Cutaneous lupus erythematosus 18.07 12.97 9 10961 2703 63475349
Rash pruritic 18.06 12.97 35 10935 59764 63418288
Skin abrasion 17.88 12.97 14 10956 9315 63468737
Cortisol decreased 17.60 12.97 7 10963 1237 63476815
Incorrect product administration duration 17.26 12.97 15 10955 11531 63466521
Drug ineffective 16.42 12.97 262 10708 1044503 62433549
Rheumatoid arthritis 16.35 12.97 12 10958 253807 63224245
Seborrhoeic keratosis 16.28 12.97 8 10962 2334 63475718
Pustular psoriasis 16.07 12.97 10 10960 4616 63473436
Infected dermal cyst 15.72 12.97 5 10965 462 63477590
Arthropathy 15.25 12.97 11 10959 234781 63243271
Pterygium 15.02 12.97 4 10966 197 63477855
Nasal polypectomy 15.01 12.97 3 10967 40 63478012
Poikiloderma 14.50 12.97 4 10966 225 63477827
Burning sensation 14.23 12.97 30 10940 54377 63423675
Rash pustular 14.11 12.97 11 10959 7271 63470781
Lipohypertrophy 13.98 12.97 5 10965 660 63477392
Skin infection 13.93 12.97 15 10955 14987 63463065
Product physical consistency issue 13.74 12.97 5 10965 694 63477358
Hirsutism 13.53 12.97 6 10964 1389 63476663
Terminal ileitis 13.42 12.97 5 10965 741 63477311
Skin weeping 13.38 12.97 5 10965 748 63477304
Skin swelling 13.35 12.97 8 10962 3451 63474601
Therapeutic response shortened 13.05 12.97 13 10957 11875 63466177

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 153.14 16.82 89 5616 38723 34912503
Skin exfoliation 100.47 16.82 60 5645 27372 34923854
Dermatitis atopic 95.18 16.82 35 5670 5312 34945914
Dry skin 67.08 16.82 49 5656 31238 34919988
Pruritus 65.54 16.82 97 5608 141884 34809342
Human herpesvirus 8 infection 48.86 16.82 14 5691 961 34950265
Rash 47.51 16.82 109 5596 222643 34728583
Skin fissures 43.86 16.82 20 5685 5239 34945987
Eczema 42.06 16.82 30 5675 18406 34932820
Folliculitis 30.80 16.82 15 5690 4551 34946675
Drug ineffective 26.46 16.82 145 5560 456606 34494620
Product dose omission issue 25.88 16.82 59 5646 119652 34831574
Cushing's syndrome 25.57 16.82 7 5698 406 34950820
Psoriatic arthropathy 25.41 16.82 23 5682 19775 34931451
Skin atrophy 24.10 16.82 10 5695 2087 34949139
Pemphigoid 21.85 16.82 15 5690 8651 34942575
Skin haemorrhage 21.83 16.82 12 5693 4666 34946560
Death 20.42 16.82 21 5684 398028 34553198
Cellulitis 19.91 16.82 33 5672 52918 34898308
Erythema 19.44 16.82 44 5661 88736 34862490
Angioplasty 19.41 16.82 7 5698 1003 34950223
Product use in unapproved indication 19.15 16.82 52 5653 117447 34833779
Necrotising fasciitis 18.63 16.82 10 5695 3712 34947514
Adrenal suppression 18.35 16.82 6 5699 641 34950585

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 217.12 13.94 149 12403 89438 79642398
Skin atrophy 180.48 13.94 57 12495 5661 79726175
Cushing's syndrome 149.13 13.94 34 12518 961 79730875
Squamous cell carcinoma of skin 120.93 13.94 54 12498 13979 79717857
Skin exfoliation 115.63 13.94 84 12468 55016 79676820
Dermatitis atopic 87.61 13.94 39 12513 10017 79721819
Pruritus 85.19 13.94 190 12362 394458 79337378
Skin fissures 83.79 13.94 41 12511 13032 79718804
Dry skin 79.95 13.94 74 12478 67921 79663915
Eczema 67.47 13.94 54 12498 40764 79691072
Incorrect product administration duration 63.27 13.94 33 12519 11989 79719847
Product use in unapproved indication 55.55 13.94 122 12430 250237 79481599
Skin haemorrhage 46.77 13.94 27 12525 11954 79719882
Delayed myelination 46.54 13.94 6 12546 0 79731836
Neoplasm skin 46.46 13.94 15 12537 1596 79730240
Necrotising fasciitis 44.93 13.94 21 12531 6029 79725807
Ochronosis 32.35 13.94 6 12546 58 79731778
Adrenal suppression 32.25 13.94 11 12541 1388 79730448
Pemphigoid 31.31 13.94 23 12529 15292 79716544
Cushingoid 30.71 13.94 19 12533 9533 79722303
Biliary sepsis 30.69 13.94 11 12541 1606 79730230
Rash 29.38 13.94 173 12379 578185 79153651
Skin striae 29.03 13.94 11 12541 1877 79729959
Steroid diabetes 28.63 13.94 13 12539 3493 79728343
Product dose omission issue 27.87 13.94 94 12458 247443 79484393
Cortisol decreased 27.53 13.94 11 12541 2161 79729675
Chorioretinopathy 27.24 13.94 11 12541 2220 79729616
Erythema 27.11 13.94 87 12465 223203 79508633
Adrenal insufficiency 25.98 13.94 27 12525 28460 79703376
Human herpesvirus 8 infection 25.82 13.94 9 12543 1211 79730625
Skin burning sensation 25.05 13.94 19 12533 13253 79718583
Toxicity to various agents 23.68 13.94 19 12533 421521 79310315
Psoriatic arthropathy 23.21 13.94 43 12509 77956 79653880
Resting tremor 20.31 13.94 8 12544 1513 79730323
Injection site pain 19.93 13.94 55 12497 129783 79602053
Drug interaction 18.40 13.94 23 12529 415160 79316676
Tinea capitis 18.25 13.94 3 12549 13 79731823
Alopecia scarring 17.97 13.94 4 12548 101 79731735
Hypothalamic pituitary adrenal axis suppression 17.81 13.94 5 12547 330 79731506
Dermatitis bullous 17.69 13.94 16 12536 14229 79717607
Dermatitis exfoliative generalised 17.39 13.94 12 12540 7229 79724607
Dermatitis 17.31 13.94 19 12533 21302 79710534
Rash pruritic 17.09 13.94 36 12516 71593 79660243
Lipohypertrophy 16.73 13.94 6 12546 878 79730958
Death 16.41 13.94 41 12511 566473 79165363
Neuralgia 16.22 13.94 23 12529 33361 79698475
Cutaneous T-cell lymphoma 15.90 13.94 8 12544 2695 79729141
Pain of skin 15.43 13.94 15 12537 14598 79717238
Off label use 15.17 13.94 213 12339 907002 78824834
Chemical burn 15.00 13.94 5 12547 588 79731248
Beta haemolytic streptococcal infection 14.71 13.94 7 12545 2090 79729746
Cellulitis 14.61 13.94 44 12508 109016 79622820
Inappropriate schedule of product administration 14.36 13.94 50 12502 133578 79598258
Hirsutism 14.12 13.94 6 12546 1376 79730460

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D07AD01 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, very potent (group IV)
ATC D07CD01 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS
Corticosteroids, very potent, combinations with antibiotics
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:35472 anti-inflammatory drugs
CHEBI has role CHEBI:131809 smoothened receptor agonists

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

DiseaseRelationSNOMED_IDDOID
Atopic dermatitis indication 24079001 DOID:3310
Contact dermatitis indication 40275004 DOID:2773
Seborrheic dermatitis indication 50563003 DOID:8741
Nummular eczema indication 81418003
Plaque psoriasis indication 200965009
Scalp psoriasis indication 238608008
Dermatosis of scalp indication 402694007 DOID:3136
Inflammatory dermatosis indication 703938007
Folliculitis contraindication 13600006 DOID:4409
Glaucoma contraindication 23986001 DOID:1686
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperglycemia contraindication 80394007 DOID:4195
Open wound contraindication 125643001
Skin striae contraindication 201066002
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Atrophoderma contraindication 399979006
Peripheral vascular disease contraindication 400047006




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 11.48 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.05% OLUX E MYLAN N022013 Jan. 12, 2007 RX AEROSOL, FOAM TOPICAL 8962000 Aug. 31, 2025 TREATMENT OF CORTICOSTEROID-RESPONSIVE DERMATOSES
0.05% OLUX E MYLAN N022013 Jan. 12, 2007 RX AEROSOL, FOAM TOPICAL 8460641 Nov. 5, 2028 TREATMENT OF CORTICOSTEROID-RESPONSIVE DERMATOSES
0.025% IMPOYZ PRIMUS PHARMS N209483 Nov. 28, 2017 RX CREAM TOPICAL 10064875 Aug. 31, 2030 PSORIASIS
0.025% IMPOYZ PRIMUS PHARMS N209483 Nov. 28, 2017 RX CREAM TOPICAL 10064875 Aug. 31, 2030 TREATMENT OF MODERATE PLAQUE PSORIASIS
0.025% IMPOYZ PRIMUS PHARMS N209483 Nov. 28, 2017 RX CREAM TOPICAL 10064875 Aug. 31, 2030 TREATMENT OF PLAQUE PSORIASIS
0.025% IMPOYZ PRIMUS PHARMS N209483 Nov. 28, 2017 RX CREAM TOPICAL 10064875 Aug. 31, 2030 TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER
0.025% IMPOYZ PRIMUS PHARMS N209483 Nov. 28, 2017 RX CREAM TOPICAL 10064875 Aug. 31, 2030 TWICE DAILY TOPICAL TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS.
0.025% IMPOYZ PRIMUS PHARMS N209483 Nov. 28, 2017 RX CREAM TOPICAL 10588914 Aug. 31, 2030 TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER
0.025% IMPOYZ PRIMUS PHARMS N209483 Nov. 28, 2017 RX CREAM TOPICAL 9956231 Aug. 31, 2030 PLAQUE PSORIASIS
0.025% IMPOYZ PRIMUS PHARMS N209483 Nov. 28, 2017 RX CREAM TOPICAL 9956231 Aug. 31, 2030 PSORIASIS
0.025% IMPOYZ PRIMUS PHARMS N209483 Nov. 28, 2017 RX CREAM TOPICAL 9956231 Aug. 31, 2030 TREATMENT OF MODERATE PLAQUE PSORIASIS
0.025% IMPOYZ PRIMUS PHARMS N209483 Nov. 28, 2017 RX CREAM TOPICAL 9956231 Aug. 31, 2030 TREATMENT OF PLAQUE PSORIASIS
0.025% IMPOYZ PRIMUS PHARMS N209483 Nov. 28, 2017 RX CREAM TOPICAL 9956231 Aug. 31, 2030 TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER
0.025% IMPOYZ PRIMUS PHARMS N209483 Nov. 28, 2017 RX CREAM TOPICAL 9956231 Aug. 31, 2030 TWICE DAILY TOPICAL TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS.

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 9.18 DRUG MATRIX CHEMBL
Annexin A1 Cytosolic other WOMBAT-PK
Bile salt export pump Transporter IC50 5.07 CHEMBL
Cytochrome P450 3A5 Enzyme IC50 7.68 CHEMBL
Androgen receptor Transcription factor Ki 5.60 DRUG MATRIX
Progesterone receptor Transcription factor Ki 8.82 DRUG MATRIX
Glucocorticoid receptor Transcription factor IC50 8.50 CHEMBL
Bile salt export pump Transporter IC50 4.46 CHEMBL

External reference:

IDSource
D01272 KEGG_DRUG
4018898 VUID
N0000179087 NUI
4018898 VANDF
4019684 VANDF
CHEBI:31414 CHEBI
CHEBI:205919 CHEBI
XRD PDB_CHEM_ID
CHEMBL1159650 ChEMBL_ID
DB01013 DRUGBANK_ID
7062 IUPHAR_LIGAND_ID
779619577M UNII
32798 PUBCHEM_CID
DB11750 DRUGBANK_ID
21245 RXNORM
300 MMSL
4471 MMSL
72591 MMSL
002203 NDDF
004480 NDDF
32197004 SNOMEDCT_US
419129004 SNOMEDCT_US
48614001 SNOMEDCT_US
C0055895 UMLSCUI
D002990 MESH_DESCRIPTOR_UI
C0008992 UMLSCUI
3154 INN_ID
25122-41-2 SECONDARY_CAS_RN
5311051 PUBCHEM_CID
ADN79D536H UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Clobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0162 OINTMENT 0.50 mg TOPICAL ANDA 20 sections
Clobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0163 CREAM 0.50 mg TOPICAL ANDA 20 sections
Clobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0269 SOLUTION 0.50 mg TOPICAL ANDA 18 sections
Clobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0293 GEL 0.50 mg TOPICAL ANDA 20 sections
Clobetasol Propionate (emollient) HUMAN PRESCRIPTION DRUG LABEL 1 0168-0301 CREAM 0.50 mg TOPICAL ANDA 25 sections
Clobex HUMAN PRESCRIPTION DRUG LABEL 1 0299-3847 SHAMPOO 0.05 g TOPICAL NDA 25 sections
Clobex HUMAN PRESCRIPTION DRUG LABEL 1 0299-3847 SHAMPOO 0.05 g TOPICAL NDA 25 sections
Clobex HUMAN PRESCRIPTION DRUG LABEL 1 0299-3848 LOTION 0.05 g TOPICAL NDA 25 sections
CLOBEX HUMAN PRESCRIPTION DRUG LABEL 1 0299-3849 SPRAY 0.05 g TOPICAL NDA 26 sections
CLOBEX HUMAN PRESCRIPTION DRUG LABEL 1 0299-3849 SPRAY 0.05 g TOPICAL NDA 26 sections
Clobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0378-8055 AEROSOL, FOAM 0.50 mg TOPICAL NDA authorized generic 27 sections
Clobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0378-8055 AEROSOL, FOAM 0.50 mg TOPICAL NDA authorized generic 27 sections
OLUX-E HUMAN PRESCRIPTION DRUG LABEL 1 0378-8147 AEROSOL, FOAM 0.50 mg TOPICAL NDA 26 sections
OLUX-E HUMAN PRESCRIPTION DRUG LABEL 1 0378-8147 AEROSOL, FOAM 0.50 mg TOPICAL NDA 26 sections
clobetasol propionate HUMAN PRESCRIPTION DRUG LABEL 1 0378-8167 AEROSOL, FOAM 0.50 mg TOPICAL NDA authorized generic 26 sections
OLUX HUMAN PRESCRIPTION DRUG LABEL 1 0378-8182 AEROSOL, FOAM 0.50 mg TOPICAL NDA 26 sections
Temovate Scalp Application HUMAN PRESCRIPTION DRUG LABEL 1 0462-0269 SOLUTION 0.50 mg TOPICAL NDA 20 sections
Temovate HUMAN PRESCRIPTION DRUG LABEL 1 0462-0293 GEL 0.50 mg TOPICAL NDA 21 sections
Clobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0472-0400 CREAM 0.50 mg TOPICAL ANDA 19 sections
Clobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0472-0402 SOLUTION 0.50 mg TOPICAL ANDA 13 sections
Clobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0472-0403 SHAMPOO 0.05 g TOPICAL ANDA 18 sections
Clobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0472-0404 LOTION 0.05 g TOPICAL ANDA 17 sections
CLOBETASOL PROPIONATE HUMAN PRESCRIPTION DRUG LABEL 1 0591-4039 SPRAY 0.05 g TOPICAL NDA authorized generic 26 sections
CLOBETASOL PROPIONATE HUMAN PRESCRIPTION DRUG LABEL 1 0591-4039 SPRAY 0.05 g TOPICAL NDA authorized generic 26 sections
Clobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0656 OINTMENT 0.50 mg TOPICAL ANDA 19 sections
Clobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0656 OINTMENT 0.50 mg TOPICAL ANDA 19 sections
clobetasol propionate HUMAN PRESCRIPTION DRUG LABEL 1 0781-7137 SHAMPOO 0.05 g TOPICAL NDA authorized generic 25 sections
Temovate HUMAN PRESCRIPTION DRUG LABEL 1 10337-162 OINTMENT 0.50 mg TOPICAL ANDA 21 sections
Temovate HUMAN PRESCRIPTION DRUG LABEL 1 10337-162 OINTMENT 0.50 mg TOPICAL ANDA 21 sections
Temovate HUMAN PRESCRIPTION DRUG LABEL 1 10337-163 CREAM 0.50 mg TOPICAL ANDA 21 sections