nicotine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
1920 54-11-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • nicotine
  • L-Nicotine
  • (S)-Nicotine
  • (-)-Nicotine
  • nicotine bitartrate anhydrous
  • nicotine polacrilex
Devices or delivery systems used to aid in ending a TOBACCO habit.
  • Molecular weight: 162.24
  • Formula: C10H14N2
  • CLOGP: 0.88
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 0
  • TPSA: 16.13
  • ALOGS: -0.24
  • ROTB: 1

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
30 mg Chewing gum
60 mg Inhal
30 mg N
30 mg SL
14 mg TD

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 16.70 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 3.52 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 30 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 2.60 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 18 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.95 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 7, 1991 FDA SANOFI AVENTIS US

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
Nicotine dependence 549.54 13.33 100 13453 423 46672086
Drug withdrawal syndrome neonatal 278.45 13.33 72 13481 1856 46670653
Drug dependence 256.39 13.33 122 13431 19779 46652730
Foetal exposure during pregnancy 219.66 13.33 127 13426 30620 46641889
Incorrect product administration duration 208.74 13.33 85 13468 9492 46663017
Premature delivery 201.04 13.33 107 13446 21962 46650547
Maternal exposure during pregnancy 178.14 13.33 182 13371 102367 46570142
Product adhesion issue 176.69 13.33 63 13490 4892 46667617
Overdose 159.24 13.33 171 13382 101808 46570701
Myocardial stunning 99.58 13.33 20 13533 155 46672354
Intentional product misuse 82.31 13.33 84 13469 47044 46625465
Application site erythema 81.76 13.33 36 13517 4868 46667641
Jaundice neonatal 81.22 13.33 23 13530 840 46671669
Dependence 78.20 13.33 27 13526 1904 46670605
Accidental overdose 76.66 13.33 56 13497 20010 46652499
Exposure during pregnancy 72.53 13.33 120 13433 108092 46564417
Application site pruritus 71.92 13.33 31 13522 3982 46668527
Necrosis ischaemic 68.28 13.33 20 13533 825 46671684
Poor feeding infant 67.44 13.33 15 13538 198 46672311
Rhesus incompatibility 61.33 13.33 12 13541 80 46672429
Product quality issue 59.45 13.33 62 13491 35586 46636923
Premature baby 59.09 13.33 46 13507 18066 46654443
Pneumonia streptococcal 58.34 13.33 21 13532 1674 46670835
Oligohydramnios 56.88 13.33 29 13524 5436 46667073
Maternal exposure during breast feeding 54.80 13.33 23 13530 2766 46669743
Beta haemolytic streptococcal infection 52.49 13.33 20 13533 1869 46670640
Drug abuse 51.73 13.33 77 13476 63331 46609178
Low birth weight baby 51.28 13.33 27 13526 5407 46667102
Rheumatoid arthritis 46.79 13.33 7 13546 240208 46432301
Exposure via breast milk 43.73 13.33 16 13537 1336 46671173
Treatment noncompliance 39.65 13.33 46 13507 29685 46642824
Chronic obstructive pulmonary disease 38.68 13.33 64 13489 57569 46614940
Congenital tricuspid valve incompetence 38.47 13.33 8 13545 75 46672434
Application site rash 36.83 13.33 17 13536 2565 46669944
Application site reaction 36.51 13.33 12 13541 727 46671782
Tobacco abuse 33.62 13.33 11 13542 657 46671852
Congenital pulmonary hypertension 32.98 13.33 7 13546 73 46672436
Substance abuse 31.82 13.33 18 13535 4149 46668360
Anxiety 31.46 13.33 120 13433 181837 46490672
Developmental hip dysplasia 30.05 13.33 12 13541 1271 46671238
Premature separation of placenta 29.82 13.33 13 13540 1715 46670794
Macular degeneration 29.54 13.33 21 13532 7184 46665325
Agitation neonatal 28.21 13.33 9 13544 496 46672013
Dysmetropsia 27.28 13.33 6 13547 75 46672434
Maternal drugs affecting foetus 27.16 13.33 18 13535 5500 46667009
Loss of proprioception 26.77 13.33 8 13545 354 46672155
Caesarean section 26.11 13.33 28 13525 16575 46655934
Application site irritation 26.01 13.33 12 13541 1807 46670702
Xanthogranuloma 24.92 13.33 4 13549 6 46672503
Application site swelling 23.17 13.33 8 13545 564 46671945
Premature labour 23.16 13.33 22 13531 11277 46661232
Symphysiolysis 23.04 13.33 4 13549 12 46672497
Abnormal dreams 22.97 13.33 21 13532 10258 46662251
Axonal neuropathy 22.18 13.33 9 13544 993 46671516
Application site dermatitis 21.40 13.33 6 13547 211 46672298
Fatigue 21.16 13.33 98 13455 608599 46063910
Product use issue 20.26 13.33 67 13486 94577 46577932
Toxicity to various agents 19.24 13.33 116 13437 211650 46460859
Cardiac death 19.23 13.33 7 13546 576 46671933
Irritability 19.21 13.33 32 13521 28914 46643595
Abortion induced 19.20 13.33 19 13534 10241 46662268
Pre-eclampsia 19.18 13.33 17 13536 7977 46664532
Application site vesicles 18.90 13.33 9 13544 1455 46671054
Respiratory failure 18.43 13.33 65 13488 94751 46577758
Oophoritis 18.18 13.33 4 13549 50 46672459
Nightmare 17.78 13.33 23 13530 16575 46655934
Withdrawal syndrome 17.69 13.33 24 13529 18110 46654399
Reversible cerebral vasoconstriction syndrome 17.54 13.33 9 13544 1708 46670801
Drug screen positive 17.49 13.33 12 13541 3879 46668630
Prinzmetal angina 17.47 13.33 7 13546 748 46671761
Selective eating disorder 17.41 13.33 9 13544 1736 46670773
Application site pain 17.13 13.33 12 13541 4011 46668498
Application site burn 16.68 13.33 7 13546 841 46671668
Application site scar 16.48 13.33 5 13548 233 46672276
Schizoaffective disorder 15.97 13.33 8 13545 1444 46671065
Loss of consciousness 15.97 13.33 68 13485 108170 46564339
Tobacco poisoning 15.94 13.33 4 13549 91 46672418
False positive investigation result 15.86 13.33 6 13547 550 46671959
Truncus arteriosus persistent 15.85 13.33 4 13549 93 46672416
Foetal growth restriction 15.83 13.33 14 13539 6553 46665956
Off label use 15.76 13.33 57 13496 379784 46292725
Alopecia 15.01 13.33 15 13538 162399 46510110
Tobacco interaction 14.64 13.33 3 13550 26 46672483
Drug abuser 14.60 13.33 10 13543 3223 46669286
Congenital cardiovascular anomaly 14.15 13.33 4 13549 145 46672364
Foetal distress syndrome 14.07 13.33 7 13546 1246 46671263
Pyrexia 14.03 13.33 53 13500 348749 46323760
Application site warmth 13.80 13.33 4 13549 159 46672350
Derealisation 13.72 13.33 6 13547 797 46671712
Injection site pain 13.69 13.33 7 13546 107145 46565364
Pain 13.62 13.33 82 13471 476866 46195643
Treatment failure 13.61 13.33 5 13548 93082 46579427
Gastric dilatation 13.52 13.33 6 13547 826 46671683

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
Nicotine dependence 424.64 13.44 77 11482 220 29940699
Drug withdrawal syndrome neonatal 285.40 13.44 87 11472 3088 29937831
Drug dependence 265.92 13.44 140 11419 21155 29919764
Incorrect product administration duration 231.26 13.44 78 11481 3844 29937075
Foetal exposure during pregnancy 218.33 13.44 150 11409 36721 29904198
Intentional product misuse 133.43 13.44 109 11450 34558 29906361
Accidental overdose 131.41 13.44 84 11475 18191 29922728
Product adhesion issue 114.16 13.44 36 11523 1429 29939490
Overdose 110.81 13.44 149 11410 84188 29856731
Maternal exposure during breast feeding 98.32 13.44 33 11526 1599 29939320
Premature baby 89.54 13.44 64 11495 16627 29924292
Dependence 70.73 13.44 24 11535 1202 29939717
Jaundice neonatal 69.33 13.44 23 11536 1074 29939845
Low birth weight baby 67.47 13.44 37 11522 6039 29934880
Exposure via breast milk 61.24 13.44 23 11536 1549 29939370
Alcohol abuse 60.55 13.44 33 11526 5320 29935599
Tobacco poisoning 52.92 13.44 9 11550 15 29940904
Foetal disorder 50.56 13.44 16 11543 642 29940277
Drug abuser 46.66 13.44 26 11533 4375 29936544
Drug screen positive 46.63 13.44 26 11533 4381 29936538
Toxicity to various agents 43.06 13.44 158 11401 177025 29763894
Poor feeding infant 40.98 13.44 12 11547 369 29940550
Neutropenia neonatal 40.92 13.44 13 11546 528 29940391
Tremor neonatal 40.76 13.44 12 11547 376 29940543
Body temperature abnormal 38.49 13.44 12 11547 458 29940461
Foetal distress syndrome 36.79 13.44 14 11545 977 29939942
Breech presentation 35.74 13.44 9 11550 154 29940765
Application site pruritus 35.58 13.44 15 11544 1368 29939551
Tobacco abuse 31.82 13.44 10 11549 392 29940527
Drug abuse 30.71 13.44 85 11474 81987 29858932
Substance abuse 28.86 13.44 23 11536 7017 29933902
Application site erythema 28.29 13.44 15 11544 2288 29938631
Laryngeal dysplasia 27.44 13.44 4 11555 0 29940919
Application site reaction 26.83 13.44 9 11550 435 29940484
Schizophrenia 25.77 13.44 24 11535 9024 29931895
Tobacco user 25.13 13.44 9 11550 529 29940390
Withdrawal syndrome 24.90 13.44 26 11533 11224 29929695
Drug withdrawal syndrome 24.42 13.44 34 11525 19775 29921144
Product quality issue 24.31 13.44 33 11526 18741 29922178
Venolymphatic malformation 23.12 13.44 5 11554 42 29940877
Off label use 23.05 13.44 38 11521 249252 29691667
Treatment noncompliance 22.14 13.44 37 11522 25216 29915703
Application site rash 21.36 13.44 9 11550 820 29940099
Acne infantile 20.05 13.44 5 11554 82 29940837
Euphoric mood 19.72 13.44 15 11544 4275 29936644
Renal hypoplasia 19.41 13.44 5 11554 94 29940825
Tachycardia 18.89 13.44 67 11492 73672 29867247
Application site scar 18.89 13.44 4 11555 30 29940889
Drug use disorder 18.67 13.44 13 11546 3235 29937684
Renal impairment 18.16 13.44 5 11554 84179 29856740
Myoclonic epilepsy 18.10 13.44 8 11551 818 29940101
Pulmonary valve stenosis congenital 17.35 13.44 5 11554 145 29940774
Application site vesicles 17.18 13.44 7 11552 586 29940333
Weight decrease neonatal 17.12 13.44 6 11553 331 29940588
Knee deformity 16.75 13.44 6 11553 353 29940566
Agitation neonatal 16.45 13.44 8 11551 1017 29939902
Breathing-related sleep disorder 16.43 13.44 5 11554 176 29940743
Diarrhoea 16.33 13.44 70 11489 334033 29606886
Palpitations 15.87 13.44 38 11521 33535 29907384
Death 15.60 13.44 78 11481 357205 29583714
Application site urticaria 15.49 13.44 4 11555 76 29940843
Application site pain 15.41 13.44 9 11550 1654 29939265
Anxiety 15.33 13.44 72 11487 89799 29851120
Application site discolouration 15.33 13.44 5 11554 221 29940698
Nightmare 15.29 13.44 21 11538 12055 29928864
Necrotising ulcerative gingivostomatitis 14.85 13.44 4 11555 90 29940829
Left ventricular hypertrophy 14.78 13.44 15 11544 6263 29934656
Potentiating drug interaction 14.59 13.44 13 11546 4618 29936301
Platelet count decreased 14.26 13.44 12 11547 106117 29834802
Neonatal disorder 14.18 13.44 7 11552 919 29940000
Facial asymmetry 13.96 13.44 5 11554 294 29940625
Alcohol interaction 13.52 13.44 10 11549 2732 29938187
Maternal drugs affecting foetus 13.47 13.44 12 11547 4261 29936658

Pharmacologic Action:

SourceCodeDescription
ATC N07BA01 NERVOUS SYSTEM
OTHER NERVOUS SYSTEM DRUGS
DRUGS USED IN ADDICTIVE DISORDERS
Drugs used in nicotine dependence
FDA CS M0014836 Nicotine
FDA EPC N0000175706 Cholinergic Nicotinic Agonist
MeSH PA D018678 Cholinergic Agents
MeSH PA D018679 Cholinergic Agonists
MeSH PA D005731 Ganglionic Stimulants
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018722 Nicotinic Agonists
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D000077444 Smoking Cessation Agents
CHEBI has role CHEBI:22917 botanical insecticides
CHEBI has role CHEBI:35471 psychopharmaceuticals
CHEBI has role CHEBI:35474 minor tranquilisers
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:47958 muscarinic agonists
CHEBI has role CHEBI:49110 peripheral nervous system agent
CHEBI has role CHEBI:50846 biomodulator
CHEBI has role CHEBI:50905 teratogen
CHEBI has role CHEBI:50910 agente neurotoxico
CHEBI has role CHEBI:52290 mitogens
CHEBI has role CHEBI:59163 biological marker
CHEBI has role CHEBI:76924 plant metabolites

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Nicotine dependence indication 56294008 DOID:0050742
Smoking cessation assistance indication 384742004
Pellagra indication 418186002 DOID:8457
Niacin deficiency indication 418279001
Nicotine Withdrawal Symptoms indication
Hyperlipidemia off-label use 55822004 DOID:1168
Hypophosphatemia contraindication 4996001
Alcoholism contraindication 7200002
Peptic ulcer contraindication 13200003 DOID:750
Esophagitis contraindication 16761005 DOID:11963
Myocardial infarction contraindication 22298006 DOID:5844
Hyperthyroidism contraindication 34486009 DOID:7998
Temporomandibular joint disorder contraindication 41888000
Low blood pressure contraindication 45007003
Diabetes mellitus type 1 contraindication 46635009 DOID:9744
Thromboangiitis obliterans contraindication 52403007 DOID:12918
Blood coagulation disorder contraindication 64779008 DOID:1247
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperglycemia contraindication 80394007 DOID:4195
Prinzmetal angina contraindication 87343002
Gout contraindication 90560007 DOID:13189
Magnetic resonance imaging contraindication 113091000
Liver function tests abnormal contraindication 166603001
Angina pectoris contraindication 194828000
Arterial hemorrhage contraindication 234003006
Disease of liver contraindication 235856003 DOID:409
Raynaud's phenomenon contraindication 266261006
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Pheochromocytoma contraindication 302835009
Acute coronary syndrome contraindication 394659003
Pharyngitis contraindication 405737000 DOID:2275
Disorder of coronary artery contraindication 414024009
Myocardial infarction in recovery phase contraindication 418044006
Hypertensive urgency contraindication 443482000
Life-Threatening Cardiac Arrhythmias contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.05 Basic
pKa2 3.14 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
Neuronal acetylcholine receptor; alpha4/beta2 Ion channel AGONIST Ki 8.56 WOMBAT-PK CHEMBL
Acetylcholine receptor; alpha1/beta1/delta/gamma Ion channel Ki 5.83 CHEMBL
Serotonin 3 (5-HT3) receptor Ion channel Ki 4.15 CHEMBL
Acetylcholine receptor subunit alpha Ion channel IC50 4.68 CHEMBL
Neuronal acetylcholine receptor; alpha3/beta4 Ion channel Ki 5.95 WOMBAT-PK
Neuronal acetylcholine receptor; alpha3/beta2 Ion channel Ki 7.85 WOMBAT-PK
Cytochrome P450 2A6 Enzyme IC50 5.36 WOMBAT-PK
Potassium voltage-gated channel subfamily D member 3 Ion channel IC50 7.40 WOMBAT-PK
Neuronal acetylcholine receptor subunit alpha-7 Ion channel Ki 5.39 WOMBAT-PK
Transient receptor potential cation channel subfamily A member 1 Ion channel ACTIVATOR EC50 4.80 IUPHAR
Neuronal acetylcholine receptor; alpha2/beta2 Ion channel Ki 8.26 CHEMBL
Neuronal acetylcholine receptor; alpha4/beta4 Ion channel Ki 7.64 CHEMBL
Neuronal acetylcholine receptor subunit alpha-3 Ion channel IC50 7.35 CHEMBL
Neuronal acetylcholine receptor; alpha2/beta4 Ion channel Ki 7.15 CHEMBL
Neuronal acetylcholine receptor; alpha3/alpha6/beta2/beta3 Ion channel IC50 7.07 CHEMBL
Neuronal acetylcholine receptor subunit alpha-4 Ion channel Ki 9.03 CHEMBL
Neuronal acetylcholine receptor subunit alpha-4 Ion channel IC50 8.15 CHEMBL
Neuronal acetylcholine receptor Ion channel Kd 11 CHEMBL
Neuronal acetylcholine receptor subunit alpha-9 Ion channel Kd 8.30 CHEMBL
Neuronal acetylcholine receptor subunit beta-4 Ion channel Ki 7.14 CHEMBL
Neuronal acetylcholine receptor subunit alpha-2 Ion channel Ki 7.92 CHEMBL
Neuronal acetylcholine receptor; alpha3/beta2 Ion channel Ki 9 CHEMBL
Neuronal acetylcholine receptor; alpha3/beta4 Ion channel Ki 6.70 CHEMBL
Neuronal acetylcholine receptor; alpha2/beta2 Ion channel Ki 8.26 CHEMBL
Neuronal acetylcholine receptor; alpha2/beta4 Ion channel Ki 7.15 CHEMBL
Nicotinic acetylcholine receptor alpha 5 subunit Ion channel Ki 5.61 CHEMBL
Acetylcholine receptor subunit delta Ion channel Ki 9 CHEMBL
Neuronal acetylcholine receptor; alpha4/beta4 Ion channel Ki 8.26 CHEMBL
Neuronal acetylcholine receptor; alpha4/beta2 Ion channel Kd 9.40 CHEMBL
Neuronal acetylcholine receptor subunit alpha-7 Ion channel Ki 6.89 CHEMBL
Neuronal acetylcholine receptor subunit alpha-7 Ion channel Ki 6.61 CHEMBL
Acetylcholine receptor Ion channel Ki 5.20 CHEMBL
Neuronal acetylcholine receptor subunit alpha-3 Ion channel Ki 7.33 CHEMBL
Acetylcholine receptor subunit beta-like 2 Ion channel Ki 5.57 CHEMBL
Muscarinic acetylcholine receptor GPCR IC50 4.55 CHEMBL
Lycopene cyclase Enzyme IC50 5.32 CHEMBL
Acetylcholine receptor subunit alpha Ion channel IC50 4.64 CHEMBL
Soluble acetylcholine receptor Unclassified Ki 7.52 CHEMBL
Neuronal acetylcholine receptor subunit alpha-4 Ion channel Ki 8.72 CHEMBL
Acetylcholine-binding protein Unclassified Ki 7.20 CHEMBL
Potassium voltage-gated channel subfamily D member 3 Unclassified BLOCKER IC50 7.40 IUPHAR

External reference:

IDSource
4020286 VUID
N0000148163 NUI
D03365 KEGG_DRUG
65-31-6 SECONDARY_CAS_RN
4018610 VANDF
4020286 VANDF
C0028040 UMLSCUI
CHEBI:17688 CHEBI
NCT PDB_CHEM_ID
89594 PUBCHEM_CID
DB00184 DRUGBANK_ID
CHEMBL3 ChEMBL_ID
CHEMBL1201536 ChEMBL_ID
D009538 MESH_DESCRIPTOR_UI
D061485 MESH_DESCRIPTOR_UI
2585 IUPHAR_LIGAND_ID
6M3C89ZY6R UNII
1306106 RXNORM
11529 MMSL
5173 MMSL
5174 MMSL
72003 MMSL
d00316 MMSL
001770 NDDF
003575 NDDF
323283001 SNOMEDCT_US
68540007 SNOMEDCT_US
77544001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Nicotrol HUMAN PRESCRIPTION DRUG LABEL 1 0009-5400 INHALANT 4 mg RESPIRATORY (INHALATION) NDA 29 sections
Nicotrol HUMAN PRESCRIPTION DRUG LABEL 1 0009-5401 SPRAY, METERED 10 mg NULLSAL NDA 28 sections
Good Sense Nicotine HUMAN OTC DRUG LABEL 1 0113-0029 GUM, CHEWING 2 mg ORAL ANDA 15 sections
Good Sense Nicotine HUMAN OTC DRUG LABEL 1 0113-0053 GUM, CHEWING 4 mg ORAL ANDA 15 sections
Good Sense Nicotine HUMAN OTC DRUG LABEL 1 0113-0170 GUM, CHEWING 4 mg ORAL ANDA 15 sections
good sense nicotinemint HUMAN OTC DRUG LABEL 1 0113-0206 GUM, CHEWING 2 mg ORAL ANDA 15 sections
Good Sense Nicotine HUMAN OTC DRUG LABEL 1 0113-0344 LOZENGE 2 mg ORAL ANDA 15 sections
Good Sense Nicotine HUMAN OTC DRUG LABEL 1 0113-0422 GUM, CHEWING 4 mg ORAL ANDA 15 sections
Good Sense Nicotine HUMAN OTC DRUG LABEL 1 0113-0456 GUM, CHEWING 2 mg ORAL ANDA 15 sections
Good Sense Nicotine HUMAN OTC DRUG LABEL 1 0113-0532 GUM, CHEWING 4 mg ORAL ANDA 15 sections
basic care nicotine HUMAN OTC DRUG LABEL 1 0113-0704 GUM, CHEWING 2 mg ORAL ANDA 15 sections
basic care nicotine HUMAN OTC DRUG LABEL 1 0113-0713 GUM, CHEWING 4 mg ORAL ANDA 15 sections
Good Sense Nicotine HUMAN OTC DRUG LABEL 1 0113-0734 LOZENGE 2 mg ORAL ANDA 15 sections
basic care nicotine HUMAN OTC DRUG LABEL 1 0113-0749 GUM, CHEWING 4 mg ORAL ANDA 15 sections
basic care nicotine HUMAN OTC DRUG LABEL 1 0113-0761 GUM, CHEWING 2 mg ORAL ANDA 15 sections
Good Sense Nicotine HUMAN OTC DRUG LABEL 1 0113-0854 GUM, CHEWING 4 mg ORAL ANDA 15 sections
good sense nicotine HUMAN OTC DRUG LABEL 1 0113-0873 LOZENGE 4 mg ORAL ANDA 15 sections
Good Sense Nicotine HUMAN OTC DRUG LABEL 1 0113-0957 LOZENGE 4 mg ORAL ANDA 15 sections
Good Sense Nicotine HUMAN OTC DRUG LABEL 1 0113-1125 LOZENGE 2 mg ORAL ANDA 15 sections
good sense nicotine HUMAN OTC DRUG LABEL 1 0113-1190 LOZENGE 4 mg ORAL ANDA 15 sections
good sense nicotine HUMAN OTC DRUG LABEL 1 0113-1352 GUM, CHEWING 2 mg ORAL ANDA 15 sections
basic care nicotine HUMAN OTC DRUG LABEL 1 0113-7007 LOZENGE 4 mg ORAL ANDA 14 sections
basic care nicotine HUMAN OTC DRUG LABEL 1 0113-7008 LOZENGE 2 mg ORAL ANDA 15 sections
basic care nicotine HUMAN OTC DRUG LABEL 1 0113-7029 GUM, CHEWING 2 mg ORAL ANDA 15 sections
basic care nicotine HUMAN OTC DRUG LABEL 1 0113-7124 LOZENGE 2 mg ORAL ANDA 15 sections
basic care nicotine HUMAN OTC DRUG LABEL 1 0113-7170 GUM, CHEWING 4 mg ORAL ANDA 15 sections
basic care nicotine HUMAN OTC DRUG LABEL 1 0113-7190 LOZENGE 4 mg ORAL ANDA 15 sections
Basic Care nicotine HUMAN OTC DRUG LABEL 1 0113-7201 LOZENGE 2 mg ORAL ANDA 14 sections
Basic Care nicotine HUMAN OTC DRUG LABEL 1 0113-7203 LOZENGE 4 mg ORAL ANDA 14 sections
basic care nicotine HUMAN OTC DRUG LABEL 1 0113-7344 LOZENGE 2 mg ORAL ANDA 15 sections