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

Stem definitionDrug idCAS RN
antihistaminics 671 15686-51-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • clemastine
  • meclastine
  • clemastine fumarate
A histamine H1 antagonist used as the hydrogen fumarate in hay fever, rhinitis, allergic skin conditions, and pruritus. It causes drowsiness.
  • Molecular weight: 343.90
  • Formula: C21H26ClNO
  • CLOGP: 5.45
  • LIPINSKI: 1
  • HAC: 2
  • HDO: 0
  • TPSA: 12.47
  • ALOGS: -5.93
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
2 mg O
2 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 2.30 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 5 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.39 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 37 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.679 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 2.286 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 8.204 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 32.063 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 1.200 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 6.280 % High 1
herg hERG pIC50 6.057 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 8.147 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 19.770 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 1.140 % High 1
kinase-safety-class ACVR2B,AKT1,AKT2,AKT3,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,JAK3,MAP3K7,MAPK10,MAPK12,MAPK7,MET,NTRK2,PDK2,PDK4,PDPK1,PIM2,PRKDC,SIK2,SIK3,TEK,TGFBR1 35
kinase-selectivity-class AKT3,AXL,ERBB2,GRK2,PDK4,SIK2 6
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.216 High 1
mh-clint Mouse hepatocyte intrinsic clearance 97.051 High 1
mppb Mouse plasma protein binding (% unbound) 1 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 5.236 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
pppb Pig plasma protein binding (% unbound) 4.430 % High 1
rh-clint Rat hepatocyte intrinsic clearance 151.705 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 2.320 % High 1
rppb Rat plasma protein binding (% unbound) 1.100 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 379.315 uM High 1

Approvals:

DateAgencyCompanyOrphan
Feb. 25, 1977 FDA

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
Erythema 197.55 24.11 171 8844 229075 90390357
Cytokine release syndrome 145.98 24.11 66 8949 27907 90591525
Toxic epidermal necrolysis 133.46 24.11 65 8950 32463 90586969
Dyspnoea 123.34 24.11 270 8745 880685 89738747
Leukopenia 111.40 24.11 87 8928 100623 90518809
Hydronephrosis 86.75 24.11 36 8979 12366 90607066
Mucosal erosion 69.36 24.11 19 8996 1826 90617606
Tooth erosion 64.83 24.11 14 9001 493 90618939
Allergy test positive 59.52 24.11 14 9001 728 90618704
Ileocaecal resection 58.14 24.11 13 9002 539 90618893
Chills 55.49 24.11 67 8948 131914 90487518
Drug reaction with eosinophilia and systemic symptoms 53.97 24.11 40 8975 42718 90576714
Stevens-Johnson syndrome 52.41 24.11 34 8981 29342 90590090
Cervix carcinoma stage 0 52.14 24.11 12 9003 567 90618865
Sepsis 52.02 24.11 76 8939 179738 90439694
Pulpitis dental 50.00 24.11 13 9002 1023 90618409
Stridor 47.85 24.11 18 8997 4775 90614657
Social problem 47.49 24.11 13 9002 1246 90618186
Sensory disturbance 46.35 24.11 25 8990 15388 90604044
Genital erosion 43.86 24.11 10 9005 453 90618979
Anaphylactic reaction 42.74 24.11 48 8967 87476 90531956
Anaemia 42.17 24.11 102 8913 352700 90266732
Feeling hot 41.94 24.11 45 8970 77963 90541469
Tachycardia 41.81 24.11 64 8951 157609 90461823
Intestinal anastomosis 41.76 24.11 11 9004 911 90618521
Mucosal inflammation 41.58 24.11 39 8976 57586 90561846
General physical health deterioration 40.67 24.11 101 8914 355014 90264418
Periodontitis 40.40 24.11 15 9000 3838 90615594
Angioedema 39.49 24.11 40 8975 64836 90554596
Anaphylactic shock 38.61 24.11 29 8986 31588 90587844
Cytomegalovirus infection 38.39 24.11 27 8988 26575 90592857
Conjunctivitis 38.30 24.11 27 8988 26679 90592753
Neutropenia 38.25 24.11 75 8940 224829 90394603
Colostomy 37.87 24.11 11 9004 1306 90618126
B-lymphocyte abnormalities 37.60 24.11 8 9007 262 90619170
Syncope 36.80 24.11 55 8960 132608 90486824
Abdominal discomfort 36.31 24.11 3 9012 477325 90142107
Cardiovascular disorder 35.39 24.11 20 8995 13472 90605960
Interleukin level increased 34.55 24.11 9 9006 713 90618719
Nail toxicity 34.12 24.11 8 9007 410 90619022
Mucosal disorder 33.57 24.11 12 9003 2759 90616673
Thrombocytopenia 33.56 24.11 68 8947 208657 90410775
Granuloma annulare 33.16 24.11 9 9006 835 90618597
Aortic disorder 32.99 24.11 9 9006 851 90618581
Lymphocytosis 32.65 24.11 12 9003 2985 90616447
Blood creatinine increased 32.46 24.11 45 8970 101341 90518091
Pain 31.19 24.11 32 8983 996309 89623123
Venous thrombosis limb 30.96 24.11 12 9003 3450 90615982
Circulatory collapse 30.75 24.11 23 8992 24881 90594551
Serum sickness 30.70 24.11 12 9003 3530 90615902
Leukocytosis 30.44 24.11 25 8990 30965 90588467
Blood lactate dehydrogenase increased 29.92 24.11 23 8992 25909 90593523
Febrile neutropenia 29.61 24.11 55 8960 158294 90461138
B-lymphocyte count decreased 28.24 24.11 9 9006 1460 90617972
Rash maculo-papular 28.18 24.11 27 8988 40906 90578526
Postpartum haemorrhage 27.59 24.11 10 9005 2391 90617041
Lymphangiectasia 27.29 24.11 5 9010 74 90619358
Appendicectomy 27.05 24.11 11 9004 3585 90615847
Subileus 26.91 24.11 11 9004 3633 90615799
Lymph node pain 26.53 24.11 9 9006 1772 90617660
Swelling 26.16 24.11 5 9010 419053 90200379
Rheumatoid arthritis 25.67 24.11 3 9012 362611 90256821
Neisseria infection 25.33 24.11 5 9010 112 90619320
Tumour lysis syndrome 25.19 24.11 15 9000 11137 90608295
Peripheral sensory neuropathy 25.04 24.11 14 9001 9236 90610196
Hypercreatininaemia 24.84 24.11 7 9008 746 90618686
Drug intolerance 24.65 24.11 7 9008 447584 90171848
Nausea 24.43 24.11 191 8824 1110125 89509307
Ileus 24.35 24.11 17 8998 16529 90602903

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
Cytokine release syndrome 100.79 22.70 65 5250 44462 42571558
Pyrexia 66.38 22.70 149 5166 393893 42222127
Toxic epidermal necrolysis 65.33 22.70 41 5274 26709 42589311
SARS-CoV-2 sepsis 59.24 22.70 12 5303 243 42615777
Pulpitis dental 56.05 22.70 14 5301 746 42615274
Leukopenia 55.75 22.70 57 5258 74689 42541331
Chills 49.88 22.70 60 5255 94006 42522014
Febrile neutropenia 49.05 22.70 85 5230 185618 42430402
Neutropenia 47.18 22.70 87 5228 199344 42416676
Infusion related reaction 44.65 22.70 46 5269 60760 42555260
Herpes zoster reactivation 37.19 22.70 9 5306 420 42615600
Long QT syndrome 36.37 22.70 14 5301 3153 42612867
Conjunctivitis 34.54 22.70 21 5294 12918 42603102
Electrocardiogram T wave biphasic 31.67 22.70 7 5308 218 42615802
Lacrimal duct neoplasm 31.00 22.70 5 5310 25 42615995
Mantle cell lymphoma stage III 31.00 22.70 5 5310 25 42615995
Drug therapeutic incompatibility 29.93 22.70 6 5309 115 42615905
Electrocardiogram T wave amplitude decreased 27.98 22.70 7 5308 375 42615645
Tumour lysis syndrome 26.38 22.70 22 5293 22209 42593811
Scrotal pain 25.72 22.70 8 5307 955 42615065
Guillain-Barre syndrome 25.26 22.70 14 5301 7249 42608771
Hypothalamo-pituitary disorder 24.67 22.70 8 5307 1092 42614928
Stevens-Johnson syndrome 24.37 22.70 21 5294 22157 42593863
Fibrin D dimer increased 24.16 22.70 12 5303 4973 42611047
Anaphylactic shock 23.30 22.70 21 5294 23496 42592524
Polyneuropathy 23.25 22.70 19 5296 18642 42597378

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
Erythema 192.83 20.12 205 13125 291242 110284727
Toxic epidermal necrolysis 186.28 20.12 104 13226 56623 110519346
Cytokine release syndrome 183.42 20.12 111 13219 70195 110505774
Leukopenia 153.93 20.12 134 13196 148657 110427312
Pulpitis dental 107.51 20.12 27 13303 1522 110574447
Dyspnoea 98.27 20.12 324 13006 1106548 109469421
Chills 93.52 20.12 115 13215 190465 110385504
Mucosal erosion 82.78 20.12 25 13305 2799 110573170
Conjunctivitis 77.03 20.12 49 13281 33743 110542226
Neutropenia 75.65 20.12 150 13180 374470 110201499
Pyrexia 70.80 20.12 253 13077 898012 109677957
Stevens-Johnson syndrome 69.12 20.12 52 13278 46849 110529120
Hydronephrosis 62.69 20.12 36 13294 20629 110555340
Drug reaction with eosinophilia and systemic symptoms 61.77 20.12 62 13268 82033 110493936
Febrile neutropenia 60.52 20.12 124 13206 316643 110259326
Periodontitis 60.47 20.12 23 13307 5185 110570784
Anaphylactic reaction 59.32 20.12 71 13259 114229 110461740
Anaemia 59.26 20.12 172 13158 546914 110029055
SARS-CoV-2 sepsis 59.18 20.12 12 13318 253 110575716
Tooth erosion 58.70 20.12 13 13317 423 110575546
Anaphylactic shock 54.38 20.12 47 13283 51499 110524470
Tumour lysis syndrome 54.14 20.12 38 13292 30763 110545206
Allergy test positive 53.81 20.12 14 13316 909 110575060
Feeling hot 52.96 20.12 60 13270 91046 110484923
Sepsis 49.86 20.12 117 13213 327229 110248740
Tachycardia 48.41 20.12 93 13237 226552 110349417
Angioedema 47.55 20.12 59 13271 98441 110477528
General physical health deterioration 42.47 20.12 130 13200 425165 110150804
Lymphocytosis 42.38 20.12 18 13312 5393 110570576
Polyneuropathy 41.72 20.12 33 13297 31979 110543990
Genital erosion 41.06 20.12 11 13319 800 110575169
B-lymphocyte abnormalities 39.44 20.12 8 13322 169 110575800
Sensory disturbance 39.03 20.12 25 13305 17404 110558565
Circulatory collapse 39.00 20.12 36 13294 42957 110533012
Thrombocytopenia 36.08 20.12 108 13222 348777 110227192
B-lymphocyte count decreased 34.82 20.12 12 13318 2043 110573926
Venous thrombosis limb 33.08 20.12 15 13315 5250 110570719
Leukocytosis 32.21 20.12 36 13294 53792 110522177
Syncope 31.46 20.12 73 13257 202463 110373506
Electrocardiogram T wave biphasic 31.42 20.12 7 13323 234 110575735
Granuloma annulare 31.33 20.12 9 13321 846 110575123
Abdominal discomfort 31.29 20.12 5 13325 393853 110182116
Pain 30.96 20.12 42 13288 954913 109621056
Aortic disorder 28.92 20.12 9 13321 1113 110574856
Kounis syndrome 28.38 20.12 14 13316 5911 110570058
Drug therapeutic incompatibility 28.31 20.12 6 13324 158 110575811
Guillain-Barre syndrome 28.07 20.12 17 13313 10727 110565242
Peripheral sensory neuropathy 27.97 20.12 20 13310 16660 110559309
Arthralgia 27.65 20.12 32 13298 779600 109796369
Rash maculo-papular 27.40 20.12 39 13291 74183 110501786
Nail toxicity 27.39 20.12 7 13323 423 110575546
Blood lactate dehydrogenase increased 27.12 20.12 30 13300 44304 110531665
Bronchospasm 26.80 20.12 25 13305 30214 110545755
Torsade de pointes 26.69 20.12 22 13308 22578 110553391
Infusion related reaction 26.22 20.12 103 13227 381059 110194910
Weight increased 26.11 20.12 9 13321 419635 110156334
Long QT syndrome 25.96 20.12 14 13316 7104 110568865
Interleukin level increased 25.67 20.12 9 13321 1612 110574357
Cardiovascular disorder 24.50 20.12 21 13309 22739 110553230
Lymphangiectasia 24.41 20.12 5 13325 111 110575858
Lymph node pain 24.26 20.12 9 13321 1893 110574076
Constipation 24.05 20.12 96 13234 357690 110218279
Resuscitation 23.78 20.12 10 13320 2923 110573046
Stridor 23.59 20.12 13 13317 6882 110569087
Drug intolerance 23.16 20.12 10 13320 406502 110169467
Condition aggravated 23.11 20.12 33 13297 734803 109841166
Electrocardiogram T wave amplitude decreased 22.91 20.12 7 13323 814 110575155
Arteriospasm coronary 22.76 20.12 14 13316 9086 110566883
Cytomegalovirus infection 22.18 20.12 30 13300 54414 110521555
Tryptase increased 21.96 20.12 7 13323 936 110575033
Fibrin D dimer increased 21.74 20.12 14 13316 9831 110566138
Subileus 21.64 20.12 12 13318 6425 110569544
Neisseria infection 21.34 20.12 5 13325 210 110575759
Postpartum haemorrhage 20.70 20.12 8 13322 1881 110574088
Cardiac arrest 20.40 20.12 61 13269 196692 110379277
Granulocyte count increased 20.33 20.12 8 13322 1975 110573994

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D04AA14 DERMATOLOGICALS
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
Antihistamines for topical use
ATC R06AA04 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Aminoalkyl ethers
ATC R06AA54 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Aminoalkyl ethers
CHEBI has role CHEBI:37955 H<small><sub>1</sub></small>-receptor antagonist
CHEBI has role CHEBI:48876 muscarinic antagonist
CHEBI has role CHEBI:50857 anti-allergic agent
CHEBI has role CHEBI:59683 antipruritic drug
MeSH PA D000982 Antipruritics
MeSH PA D003879 Dermatologic Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018926 Anti-Allergic Agents

Related Drugs by ATC class:

D04AA Antihistamines for topical use 13 drugs
bamipinechloropyraminechlorphenoxaminedimetindenediphenhydramineisothipendylmepyraminepheniraminepromethazinethenalidinethonzylaminetolpropamine show all 13 →
R06AA Aminoalkyl ethers 8 drugs
bromazinecarbinoxaminechlorphenoxaminedimenhydrinatediphenhydraminediphenylpyralinedoxylaminetrimethobenzamide

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

DiseaseRelationSNOMED_IDDOID
Dermatographic urticaria indication 7632005 DOID:743
Vasomotor rhinitis indication 8229003 DOID:4730
Allergic rhinitis indication 61582004
Nasal discharge indication 64531003
Nasal congestion indication 68235000
Sneezing indication 76067001
Urticaria indication 126485001
Itching of skin indication 418363000
Allergic conjunctivitis indication 473460002 DOID:11204
Anaphylaxis Adjunct indication
Ocular hypertension contraindication 4210003 DOID:9282
Peptic ulcer contraindication 13200003 DOID:750
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Chronic idiopathic constipation contraindication 82934008
Bladder outflow obstruction contraindication 236645006
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Angle-closure glaucoma contraindication 392291006 DOID:13550




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.7 Basic

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
Histamine H1 receptor GPCR ANTAGONIST Ki 8.59 WOMBAT-PK CHEMBL
D(1A) dopamine receptor GPCR Ki 6.12 DRUG MATRIX
D(2) dopamine receptor GPCR Ki 7.35 DRUG MATRIX
Alpha-2A adrenergic receptor GPCR Ki 7.16 DRUG MATRIX
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 7.85 DRUG MATRIX
Potassium voltage-gated channel subfamily H member 2 Ion channel Ki 7.92 WOMBAT-PK
Sodium-dependent noradrenaline transporter Transporter Ki 5.51 DRUG MATRIX
5-hydroxytryptamine receptor 2A GPCR Ki 8.04 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 7.64 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 7.28 DRUG MATRIX
5-hydroxytryptamine receptor 6 GPCR Ki 7.44 DRUG MATRIX
Alpha-2B adrenergic receptor GPCR Ki 6.85 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 8.60 DRUG MATRIX
Histamine H2 receptor GPCR Ki 6.44 DRUG MATRIX
Muscarinic acetylcholine receptor M1 GPCR Ki 7.80 WOMBAT-PK
Muscarinic acetylcholine receptor M3 GPCR Ki 8.08 DRUG MATRIX
Muscarinic acetylcholine receptor M4 GPCR Ki 8.56 DRUG MATRIX
Muscarinic acetylcholine receptor M5 GPCR Ki 8.22 DRUG MATRIX
Alpha-2C adrenergic receptor GPCR Ki 7.85 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 6.27 DRUG MATRIX
Cytochrome P450 2D6 Enzyme Ki 5.70 WOMBAT-PK
Alpha-1D adrenergic receptor GPCR Ki 7.82 DRUG MATRIX
Cytochrome P450 2C19 Enzyme IC50 6.22 DRUG MATRIX
Solute carrier family 22 member 1 Transporter IC50 5.31 CHEMBL
Muscarinic acetylcholine receptor M2 GPCR Ki 6.70 WOMBAT-PK
Transmembrane protein 97 Enzyme Ki 7.60 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 7.39 DRUG MATRIX
5-hydroxytryptamine receptor 1B GPCR Ki 6.66 DRUG MATRIX
Membrane-associated progesterone receptor component 1 Membrane receptor Ki 6.35 DRUG MATRIX
Alpha-1A adrenergic receptor GPCR IC50 7.28 CHEMBL

External reference:

IDSource
4019681 VUID
N0000147773 NUI
D00666 KEGG_DRUG
14976-57-9 SECONDARY_CAS_RN
142430 RXNORM
C0008929 UMLSCUI
CHEBI:3738 CHEBI
CHEMBL1626 ChEMBL_ID
CHEMBL1200795 ChEMBL_ID
DB00283 DRUGBANK_ID
D002974 MESH_DESCRIPTOR_UI
26987 PUBCHEM_CID
6063 IUPHAR_LIGAND_ID
2231 INN_ID
95QN29S1ID UNII
224 MMSL
4464 MMSL
d00780 MMSL
003410 NDDF
004441 NDDF
372744005 SNOMEDCT_US
45218006 SNOMEDCT_US
83968007 SNOMEDCT_US
4018759 VANDF
4019681 VANDF
95QN29S1ID INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Clemastine Fumarate HUMAN OTC DRUG LABEL 1 54868-5913 TABLET 1.34 mg ORAL ANDA 14 sections
CLEMASTINE FUMARATE HUMAN PRESCRIPTION DRUG LABEL 1 62135-713 SYRUP 0.67 mg ORAL ANDA 12 sections
Clemastine Fumarate HUMAN PRESCRIPTION DRUG LABEL 1 64950-268 TABLET 2.68 mg ORAL ANDA 13 sections
Clemastine Fumarate HUMAN PRESCRIPTION DRUG LABEL 1 64950-324 SYRUP 0.67 mg ORAL ANDA 21 sections
Clemastine Fumarate HUMAN OTC DRUG LABEL 1 68151-2456 TABLET 1.34 mg ORAL ANDA 14 sections
CLEMSZA HUMAN PRESCRIPTION DRUG LABEL 1 71085-081 TABLET 2.68 mg ORAL ANDA 13 sections