lamotrigine indications/contra

Stem definitionDrug idCAS RN
1540 84057-84-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • lamictal
  • lamotrigine
  • lamitrin
  • lamotrigin
  • BW 430C
blocks voltage-gated sodium and calcium channels and inhibits release of excitatory neurotransmitters such as glutamate; structure given in first source
  • Molecular weight: 256.09
  • Formula: C9H7Cl2N5
  • CLOGP: 2.53
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 90.71
  • ALOGS: -2.72
  • ROTB: 1

Drug dosage:

DoseUnitRoute
0.30 g O

Approvals:

DateAgencyCompanyOrphan
Dec. 27, 1994 FDA GLAXOSMITHKLINE LLC

FDA Adverse Event Reporting System

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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
Seizure 3908.78 37.89 1344 14810 39056 3330649
Exposure during pregnancy 3440.66 37.89 1113 15041 26450 3343255
Completed suicide 3412.16 37.89 1139 15015 29975 3339730
Foetal exposure during pregnancy 3202.92 37.89 924 15230 14627 3355078
Rash 3090.27 37.89 1319 14835 69502 3300203
Stevens-Johnson syndrome 2936.84 37.89 726 15428 6046 3363659
Drug reaction with eosinophilia and systemic symptoms 2836.03 37.89 728 15426 7167 3362538
Toxicity to various agents 2575.55 37.89 1033 15121 46021 3323684
Pyrexia 2311.23 37.89 1125 15029 79990 3289715
Product substitution issue 1636.64 37.89 469 15685 7131 3362574
Toxic epidermal necrolysis 1511.46 37.89 395 15759 4150 3365555
Drug interaction 1276.17 37.89 633 15521 46179 3323526
Drug eruption 1164.04 37.89 330 15824 4795 3364910
Epilepsy 1073.47 37.89 332 15822 6613 3363092
Intentional overdose 1026.89 37.89 391 15763 14834 3354871
Somnolence 906.91 37.89 446 15708 31758 3337947
Rash maculo-papular 896.00 37.89 278 15876 5589 3364116
Atrial septal defect 893.47 37.89 237 15917 2636 3367069
Lymphadenopathy 888.64 37.89 297 15857 7635 3362070
Generalised tonic-clonic seizure 876.69 37.89 295 15859 7747 3361958
Overdose 875.41 37.89 443 15711 33535 3336170
Suicide attempt 826.26 37.89 338 15816 15509 3354196
Rash generalised 820.13 37.89 295 15859 9487 3360218
Ataxia 764.38 37.89 227 15927 3905 3365800
Abortion spontaneous 751.89 37.89 284 15870 10501 3359204
Agitation 739.31 37.89 333 15821 19373 3350332
Erythema 733.87 37.89 373 15781 28437 3341268
Aggression 690.77 37.89 271 15883 11114 3358591
Dizziness 643.05 37.89 488 15666 76024 3293681
Tremor 623.67 37.89 332 15822 27812 3341893

Pharmacologic Action:

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SourceCodeDescription
ATC N03AX09 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Other antiepileptics
CHEBI has role CHEBI:35623 anticonvulsant
CHEBI has role CHEBI:35477 antimanic drug
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35481 non-narcotic analgesic
MeSH PA D000927 Anticonvulsants
MeSH PA D002121 Calcium Channel Blockers
MeSH PA D002317 Cardiovascular Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D018683 Excitatory Amino Acid Agents
MeSH PA D018691 Excitatory Amino Acid Antagonists
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D026941 Sodium Channel Blockers
MeSH PA D061567 Voltage-Gated Sodium Channel Blockers
FDA EPC N0000175753 Anti-epileptic Agent
FDA PE N0000008486 Decreased Central Nervous System Disorganized Electrical Activity
FDA EPC N0000175751 Mood Stabilizer

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Tonic-clonic seizure indication 54200006
Epilepsy indication 84757009 DOID:1826
Bipolar disorder in remission indication 85248005
Lennox-Gastaut syndrome indication 230418006
Epilepsy characterized by intractable complex partial seizures indication 442481002
Simple partial seizure indication 117891000119100
Suicidal thoughts contraindication 6471006
Depressive disorder contraindication 35489007 DOID:2848
Acute nephropathy contraindication 58574008
Pancytopenia contraindication 127034005 DOID:12450
Non-infective meningitis contraindication 230155003
Disease of liver contraindication 235856003 DOID:409
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Aplastic anemia contraindication 306058006 DOID:12449
Bipolar affective disorder, current episode depression off-label use 191627008 DOID:3312
Neuropathic pain off-label use 247398009
Rapid Cycling Bipolar Affective Disorder off-label use

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 5.3 Basic
pKa2 0.0 Basic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG LAMICTAL ODT GLAXOSMITHKLINE LLC N022251 May 8, 2009 RX TABLET, ORALLY DISINTEGRATING ORAL 8840925 July 2, 2028 LAMICTAL IS AN ANTIEPILEPTIC DRUG (AED) INDICATED FOR: EPILEPSY-ADJUNCTIVE THERAPY IN PATIENTS GREATER THAN OR EQUAL TO 2 YEARS OF AGE: (1.1) PARTIAL SEIZURES PRIMARY GENERALIZED TONIC-CLONIC SEIZURES
100MG LAMICTAL ODT GLAXOSMITHKLINE LLC N022251 May 8, 2009 RX TABLET, ORALLY DISINTEGRATING ORAL 9339504 July 2, 2028 LAMICTAL IS AN ANTIEPILEPTIC DRUG (AED) INDICATED FOR: EPILEPSY-ADJUNCTIVE THERAPY IN PATIENTS GREATER THAN OR EQUAL TO 2 YEARS OF AGE: (1.1) PARTIAL SEIZURES PRIMARY GENERALIZED TONIC-CLONIC SEIZURES
200MG LAMICTAL ODT GLAXOSMITHKLINE LLC N022251 May 8, 2009 RX TABLET, ORALLY DISINTEGRATING ORAL 8840925 July 2, 2028 LAMICTAL IS AN ANTIEPILEPTIC DRUG (AED) INDICATED FOR: EPILEPSY-ADJUNCTIVE THERAPY IN PATIENTS GREATER THAN OR EQUAL TO 2 YEARS OF AGE: (1.1) PARTIAL SEIZURES PRIMARY GENERALIZED TONIC-CLONIC SEIZURES
200MG LAMICTAL ODT GLAXOSMITHKLINE LLC N022251 May 8, 2009 RX TABLET, ORALLY DISINTEGRATING ORAL 9339504 July 2, 2028 LAMICTAL IS AN ANTIEPILEPTIC DRUG (AED) INDICATED FOR: EPILEPSY-ADJUNCTIVE THERAPY IN PATIENTS GREATER THAN OR EQUAL TO 2 YEARS OF AGE: (1.1) PARTIAL SEIZURES PRIMARY GENERALIZED TONIC-CLONIC SEIZURES
25MG LAMICTAL ODT GLAXOSMITHKLINE LLC N022251 May 8, 2009 RX TABLET, ORALLY DISINTEGRATING ORAL 8840925 July 2, 2028 LAMICTAL IS AN ANTIEPILEPTIC DRUG (AED) INDICATED FOR: EPILEPSY-ADJUNCTIVE THERAPY IN PATIENTS GREATER THAN OR EQUAL TO 2 YEARS OF AGE: (1.1) PARTIAL SEIZURES PRIMARY GENERALIZED TONIC-CLONIC SEIZURES
25MG LAMICTAL ODT GLAXOSMITHKLINE LLC N022251 May 8, 2009 RX TABLET, ORALLY DISINTEGRATING ORAL 9339504 July 2, 2028 LAMICTAL IS AN ANTIEPILEPTIC DRUG (AED) INDICATED FOR: EPILEPSY-ADJUNCTIVE THERAPY IN PATIENTS GREATER THAN OR EQUAL TO 2 YEARS OF AGE: (1.1) PARTIAL SEIZURES PRIMARY GENERALIZED TONIC-CLONIC SEIZURES
50MG LAMICTAL ODT GLAXOSMITHKLINE LLC N022251 May 8, 2009 RX TABLET, ORALLY DISINTEGRATING ORAL 8840925 July 2, 2028 LAMICTAL IS AN ANTIEPILEPTIC DRUG (AED) INDICATED FOR: EPILEPSY-ADJUNCTIVE THERAPY IN PATIENTS GREATER THAN OR EQUAL TO 2 YEARS OF AGE: (1.1) PARTIAL SEIZURES PRIMARY GENERALIZED TONIC-CLONIC SEIZURES
50MG LAMICTAL ODT GLAXOSMITHKLINE LLC N022251 May 8, 2009 RX TABLET, ORALLY DISINTEGRATING ORAL 9339504 July 2, 2028 LAMICTAL IS AN ANTIEPILEPTIC DRUG (AED) INDICATED FOR: EPILEPSY-ADJUNCTIVE THERAPY IN PATIENTS GREATER THAN OR EQUAL TO 2 YEARS OF AGE: (1.1) PARTIAL SEIZURES PRIMARY GENERALIZED TONIC-CLONIC SEIZURES

Orange Book exclusivity data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG LAMICTAL GLAXOSMITHKLINE LLC N020241 Dec. 27, 1994 RX TABLET ORAL May 18, 2018 ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
150MG LAMICTAL GLAXOSMITHKLINE LLC N020241 Dec. 27, 1994 RX TABLET ORAL May 18, 2018 ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
200MG LAMICTAL GLAXOSMITHKLINE LLC N020241 Dec. 27, 1994 RX TABLET ORAL May 18, 2018 ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** LAMICTAL GLAXOSMITHKLINE LLC N020241 Dec. 27, 1994 DISCN TABLET ORAL May 18, 2018 ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
25MG LAMICTAL GLAXOSMITHKLINE LLC N020241 Dec. 27, 1994 RX TABLET ORAL May 18, 2018 ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** LAMICTAL GLAXOSMITHKLINE LLC N020241 Dec. 27, 1994 DISCN TABLET ORAL May 18, 2018 ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
100MG LAMICTAL CD GLAXOSMITHKLINE LLC N020764 Aug. 24, 1998 DISCN TABLET, CHEWABLE ORAL May 18, 2018 ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
25MG LAMICTAL CD GLAXOSMITHKLINE LLC N020764 Aug. 24, 1998 RX TABLET, CHEWABLE ORAL May 18, 2018 ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
2MG LAMICTAL CD GLAXOSMITHKLINE LLC N020764 Sept. 8, 2000 RX TABLET, CHEWABLE ORAL May 18, 2018 ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
5MG LAMICTAL CD GLAXOSMITHKLINE LLC N020764 Aug. 24, 1998 RX TABLET, CHEWABLE ORAL May 18, 2018 ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
100MG LAMICTAL ODT GLAXOSMITHKLINE LLC N022251 May 8, 2009 RX TABLET, ORALLY DISINTEGRATING ORAL May 18, 2018 ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
200MG LAMICTAL ODT GLAXOSMITHKLINE LLC N022251 May 8, 2009 RX TABLET, ORALLY DISINTEGRATING ORAL May 18, 2018 ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
25MG LAMICTAL ODT GLAXOSMITHKLINE LLC N022251 May 8, 2009 RX TABLET, ORALLY DISINTEGRATING ORAL May 18, 2018 ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
50MG LAMICTAL ODT GLAXOSMITHKLINE LLC N022251 May 8, 2009 RX TABLET, ORALLY DISINTEGRATING ORAL May 18, 2018 ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium channel protein type 9 subunit alpha Ion channel BLOCKER IC50 4.77 CHEMBL CHEMBL
Sodium channel protein type 8 subunit alpha Ion channel BLOCKER DRUGBANK CHEMBL
Sodium channel protein type 3 subunit alpha Ion channel BLOCKER IC50 4.77 CHEMBL CHEMBL
Sodium channel protein type 1 subunit alpha Ion channel BLOCKER DRUGBANK CHEMBL
Sodium channel protein type 10 subunit alpha Ion channel BLOCKER IC50 4.02 CHEMBL CHEMBL
Sodium channel protein type 5 subunit alpha Ion channel BLOCKER IC50 4.21 CHEMBL CHEMBL
Sodium channel protein type 4 subunit alpha Ion channel BLOCKER Ki 4.77 CHEMBL CHEMBL
Sodium channel protein type 2 subunit alpha Ion channel BLOCKER IC50 5 CHEMBL CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor IC50 3.84 WOMBAT-PK
5-hydroxytryptamine receptor 3A Ion channel IC50 4.74 WOMBAT-PK
Sodium channel protein type X alpha subunit Unclassified IC50 4.60 CHEMBL
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel IC50 4.51 CHEMBL
Sodium channel protein type 2 subunit alpha Ion channel IC50 4.46 CHEMBL

External reference:

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IDSource
DB00555 DRUGBANK_ID
2622 IUPHAR_LIGAND_ID
C0678180 UMLSCUI
D00354 KEGG_DRUG
CHEMBL741 ChEMBL_ID
3878 PUBCHEM_CID
4020896 VANDF
N0000005979 NDFRT
N0000148390 NDFRT
28439 RXNORM
69610 MMSL
d03809 MMSL
003988 NDDF
4957 MMSL
387562000 SNOMEDCT_US
96195007 SNOMEDCT_US
CHEBI:6367 CHEBI
C047781 MESH_SUPPLEMENTAL_RECORD_UI
U3H27498KS UNII
5638 INN_ID

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
Lamotrigine HUMAN PRESCRIPTION DRUG LABEL 1 0093-0039 TABLET 25 mg ORAL ANDA 19 sections
Lamotrigine HUMAN PRESCRIPTION DRUG LABEL 1 0093-0132 TABLET, CHEWABLE 25 mg ORAL ANDA 19 sections
Lamotrigine HUMAN PRESCRIPTION DRUG LABEL 1 0093-0463 TABLET 100 mg ORAL ANDA 19 sections
Lamotrigine HUMAN PRESCRIPTION DRUG LABEL 1 0093-0688 TABLET, CHEWABLE 5 mg ORAL ANDA 19 sections
Lamotrigine HUMAN PRESCRIPTION DRUG LABEL 1 0093-7247 TABLET 150 mg ORAL ANDA 19 sections
Lamotrigine HUMAN PRESCRIPTION DRUG LABEL 1 0093-7248 TABLET 200 mg ORAL ANDA 19 sections
Lamotrigine HUMAN PRESCRIPTION DRUG LABEL 1 0115-1526 TABLET, ORALLY DISINTEGRATING 25 mg ORAL ANDA 19 sections
Lamotrigine HUMAN PRESCRIPTION DRUG LABEL 1 0115-1527 TABLET, ORALLY DISINTEGRATING 50 mg ORAL ANDA 19 sections
Lamotrigine HUMAN PRESCRIPTION DRUG LABEL 1 0115-1528 TABLET, ORALLY DISINTEGRATING 100 mg ORAL ANDA 19 sections
Lamotrigine HUMAN PRESCRIPTION DRUG LABEL 1 0115-1529 TABLET, ORALLY DISINTEGRATING 200 mg ORAL ANDA 19 sections
Lamotrigine HUMAN PRESCRIPTION DRUG LABEL 1 0143-9964 TABLET 200 mg ORAL ANDA 19 sections
Lamotrigine HUMAN PRESCRIPTION DRUG LABEL 1 0143-9965 TABLET 150 mg ORAL ANDA 19 sections
Lamotrigine HUMAN PRESCRIPTION DRUG LABEL 1 0143-9966 TABLET 100 mg ORAL ANDA 19 sections
Lamotrigine HUMAN PRESCRIPTION DRUG LABEL 1 0143-9967 TABLET 25 mg ORAL ANDA 19 sections
LAMICTAL HUMAN PRESCRIPTION DRUG LABEL 1 0173-0526 TABLET, CHEWABLE 5 mg ORAL NDA 18 sections
LAMICTAL HUMAN PRESCRIPTION DRUG LABEL 1 0173-0527 TABLET, CHEWABLE 25 mg ORAL NDA 18 sections
LAMICTAL HUMAN PRESCRIPTION DRUG LABEL 2 0173-0594 KIT 100 mg None NDA 18 sections
LAMICTAL HUMAN PRESCRIPTION DRUG LABEL 2 0173-0594 KIT 25 mg None NDA 18 sections
LAMICTAL HUMAN PRESCRIPTION DRUG LABEL 1 0173-0633 TABLET 25 mg ORAL NDA 18 sections
LAMICTAL HUMAN PRESCRIPTION DRUG LABEL 1 0173-0642 TABLET 100 mg ORAL NDA 18 sections
LAMICTAL HUMAN PRESCRIPTION DRUG LABEL 1 0173-0643 TABLET 150 mg ORAL NDA 18 sections
LAMICTAL HUMAN PRESCRIPTION DRUG LABEL 1 0173-0644 TABLET 200 mg ORAL NDA 18 sections
LAMICTAL HUMAN PRESCRIPTION DRUG LABEL 1 0173-0699 TABLET, CHEWABLE 2 mg ORAL NDA 18 sections
LAMICTAL HUMAN PRESCRIPTION DRUG LABEL 1 0173-0754 TABLET, FILM COATED, EXTENDED RELEASE 25 mg ORAL NDA 19 sections
LAMICTAL HUMAN PRESCRIPTION DRUG LABEL 1 0173-0755 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 19 sections
LAMICTAL HUMAN PRESCRIPTION DRUG LABEL 1 0173-0756 TABLET, FILM COATED, EXTENDED RELEASE 100 mg ORAL NDA 19 sections
LAMICTAL HUMAN PRESCRIPTION DRUG LABEL 1 0173-0757 TABLET, FILM COATED, EXTENDED RELEASE 200 mg ORAL NDA 19 sections
LAMICTAL HUMAN PRESCRIPTION DRUG LABEL 2 0173-0758 KIT 25 mg None NDA 19 sections
LAMICTAL HUMAN PRESCRIPTION DRUG LABEL 2 0173-0758 KIT 50 mg None NDA 19 sections
LAMICTAL HUMAN PRESCRIPTION DRUG LABEL 3 0173-0759 KIT 200 mg None NDA 19 sections