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

Stem definitionDrug idCAS RN
tricyclic compounds 956 1668-19-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • P-3693A
  • doxepin
  • doxepine
  • doxepin hydrochloride
  • silenor
  • doxepin HCl
A dibenzoxepin tricyclic compound. It displays a range of pharmacological actions including maintaining adrenergic innervation. Its mechanism of action is not fully understood, but it appears to block reuptake of monoaminergic neurotransmitters into presynaptic terminals. It also possesses anticholinergic activity and modulates antagonism of histamine H(1)- and H(2)-receptors.
  • Molecular weight: 279.38
  • Formula: C19H21NO
  • CLOGP: 4.09
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 0
  • TPSA: 12.47
  • ALOGS: -3.94
  • ROTB: 3

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.10 g O
0.10 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 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) 17.90 ┬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) 12 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 14 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.20 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 15 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Sept. 23, 1969 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
Completed suicide 682.25 12.86 477 17595 137724 53193270
Toxicity to various agents 400.58 12.86 429 17643 219169 53111825
Cardio-respiratory arrest 167.28 12.86 147 17925 58611 53272383
Respiratory arrest 158.23 12.86 113 17959 33427 53297567
Respiratory depression 131.93 12.86 71 18001 12735 53318259
Cardiac arrest 115.13 12.86 150 17922 93517 53237477
Drug abuse 99.93 12.86 117 17955 65409 53265585
Suicide attempt 88.91 12.86 104 17968 58064 53272930
Overdose 68.09 12.86 127 17945 107609 53223385
Intentional overdose 62.20 12.86 94 17978 67111 53263883
Rheumatoid arthritis 58.57 12.86 17 18055 314514 53016480
Suicidal ideation 57.94 12.86 86 17986 60425 53270569
Coma 52.39 12.86 83 17989 61700 53269294
Depression 51.11 12.86 157 17915 182895 53148099
Urticaria 49.13 12.86 128 17944 135757 53195237
Depressed level of consciousness 47.36 12.86 74 17998 54354 53276640
Sleep-related eating disorder 45.71 12.86 15 18057 773 53330221
Decreased bronchial secretion 42.32 12.86 9 18063 80 53330914
Electrocardiogram QRS complex prolonged 40.80 12.86 25 18047 5717 53325277
Poisoning 40.05 12.86 35 18037 13815 53317179
Insomnia 39.41 12.86 146 17926 186926 53144068
Joint swelling 36.37 12.86 17 18055 234621 53096373
Somnolence 34.56 12.86 130 17942 167604 53163390
Therapeutic product effect increased 32.85 12.86 13 18059 1150 53329844
Systemic lupus erythematosus 31.58 12.86 3 18069 125411 53205583
Skin plaque 28.56 12.86 21 18051 6483 53324511
Jaundice neonatal 28.24 12.86 11 18061 933 53330061
Paranasal sinus inflammation 27.98 12.86 9 18063 435 53330559
Infusion related reaction 27.96 12.86 9 18063 155948 53175046
Diverticulum oesophageal 27.62 12.86 7 18065 141 53330853
Sleep disorder 27.19 12.86 61 18011 58809 53272185
Lipohypertrophy 26.54 12.86 10 18062 775 53330219
Mandibular mass 25.89 12.86 7 18065 183 53330811
Restlessness 25.56 12.86 39 18033 28048 53302946
Bradypnoea 25.09 12.86 15 18057 3282 53327712
Maternal exposure during pregnancy 24.53 12.86 11 18061 155628 53175366
Therapeutic product effect decreased 22.97 12.86 7 18065 125648 53205346
Nail avulsion 22.80 12.86 6 18066 141 53330853
Exposure via ingestion 22.69 12.86 14 18058 3241 53327753
Migraine 22.42 12.86 69 18003 80348 53250646
Ventricular arrhythmia 21.18 12.86 14 18058 3646 53327348
Osteosclerosis 20.85 12.86 14 18058 3744 53327250
Febrile neutropenia 20.77 12.86 5 18067 104931 53226063
Blood glucose fluctuation 20.68 12.86 15 18057 4536 53326458
Pyrexia 20.60 12.86 69 18003 403124 52927870
Acute lung injury 20.56 12.86 10 18062 1451 53329543
Treatment failure 20.35 12.86 9 18063 128394 53202600
Affective disorder 20.17 12.86 16 18056 5523 53325471
Pruritus 20.14 12.86 169 17903 293663 53037331
Blood test abnormal 19.87 12.86 22 18050 11555 53319439
Anxiety 19.74 12.86 124 17948 196580 53134414
Mastocytosis 19.66 12.86 7 18065 462 53330532
Drug withdrawal syndrome neonatal 19.60 12.86 11 18061 2139 53328855
Intentional product misuse 19.35 12.86 48 18024 49344 53281650
Arthropathy 19.34 12.86 12 18060 141441 53189553
Contraindicated product administered 19.25 12.86 11 18061 135618 53195376
Defaecation disorder 18.85 12.86 7 18065 521 53330473
Stress 18.81 12.86 52 18020 57032 53273962
Restless legs syndrome 18.70 12.86 26 18046 17197 53313797
Self esteem decreased 18.40 12.86 7 18065 557 53330437
Product prescribing error 18.22 12.86 30 18042 23001 53307993
Dyshidrotic eczema 18.12 12.86 7 18065 581 53330413
Blood pressure systolic increased 18.00 12.86 38 18034 35139 53295855
Hypothermia 17.73 12.86 22 18050 13034 53317960
Glossodynia 17.59 12.86 6 18066 100285 53230709
Seizure 17.18 12.86 88 17984 129421 53201573
Breast adenoma 17.02 12.86 4 18068 58 53330936
Death 16.86 12.86 190 17882 357042 52973952
Sinobronchitis 16.78 12.86 5 18067 187 53330807
Metabolic acidosis 16.49 12.86 41 18031 42201 53288793
Impaired work ability 16.40 12.86 22 18050 14068 53316926
Somnambulism 16.32 12.86 14 18058 5388 53325606
Drug interaction 16.00 12.86 128 17944 219201 53111793
Allergic oedema 15.86 12.86 7 18065 814 53330180
Panic attack 15.75 12.86 27 18045 21391 53309603
Iritis 15.40 12.86 10 18062 2529 53328465
Bradycardia 15.38 12.86 56 18016 71000 53259994
Osteoporotic fracture 15.36 12.86 11 18061 3260 53327734
Drug withdrawal syndrome 15.19 12.86 31 18041 27991 53303003
Synovitis 14.96 12.86 9 18063 107884 53223110
Hepatic lesion 14.92 12.86 12 18060 4225 53326769
Choking 14.85 12.86 17 18055 9259 53321735
Tachycardia 14.68 12.86 74 17998 108138 53222856
Subendocardial ischaemia 14.64 12.86 4 18068 109 53330885
Eczema 14.62 12.86 28 18044 24154 53306840
Myofascial pain syndrome 14.37 12.86 9 18063 2137 53328857
Hepatic enzyme increased 14.30 12.86 13 18059 126182 53204812
Junctional ectopic tachycardia 13.99 12.86 4 18068 129 53330865
Product used for unknown indication 13.62 12.86 6 18066 694 53330300
Blood pressure diastolic increased 13.03 12.86 14 18058 7110 53323884
Burns second degree 13.02 12.86 6 18066 772 53330222
Scratch 12.98 12.86 12 18060 5092 53325902

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
Completed suicide 479.58 16.11 298 8185 92219 32412824
Toxicity to various agents 238.72 16.11 261 8222 177780 32327263
Drug abuse 153.58 16.11 143 8340 80100 32424943
Needle fatigue 78.55 16.11 19 8464 413 32504630
Gait spastic 75.09 16.11 19 8464 500 32504543
Relapsing-remitting multiple sclerosis 71.68 16.11 19 8464 603 32504440
Hypertonic bladder 56.32 16.11 19 8464 1392 32503651
Overdose 55.50 16.11 89 8394 86988 32418055
Monoparesis 51.18 16.11 19 8464 1842 32503201
Brugada syndrome 42.19 16.11 13 8470 712 32504331
Memory impairment 39.96 16.11 51 8432 40428 32464615
Respiratory arrest 37.73 16.11 42 8441 28866 32476177
Pulmonary oedema 36.11 16.11 52 8431 46215 32458828
Nocturia 35.78 16.11 25 8458 9269 32495774
Brain oedema 34.61 16.11 28 8455 12932 32492111
Insomnia 33.49 16.11 78 8405 100270 32404773
Cardio-respiratory arrest 32.62 16.11 55 8428 55934 32449109
Micturition urgency 31.90 16.11 19 8464 5367 32499676
Muscle spasticity 30.59 16.11 19 8464 5786 32499257
Central nervous system lesion 30.51 16.11 19 8464 5813 32499230
Intentional overdose 29.92 16.11 45 8438 41556 32463487
Hydrocholecystis 29.88 16.11 8 8475 264 32504779
Illness anxiety disorder 28.40 16.11 7 8476 165 32504878
Soft tissue haemorrhage 28.20 16.11 7 8476 170 32504873
Intentional product misuse 27.36 16.11 40 8443 36011 32469032
Erectile dysfunction 26.18 16.11 29 8454 19810 32485233
Ataxia 24.84 16.11 23 8460 12718 32492325
Drug dependence 23.82 16.11 30 8453 23454 32481589
Somatic symptom disorder 23.53 16.11 8 8475 600 32504443
Helplessness 23.37 16.11 5 8478 61 32504982
Anxiety 23.09 16.11 66 8417 95939 32409104
Dysarthria 22.58 16.11 35 8448 33166 32471877
Multiple sclerosis relapse 22.45 16.11 21 8462 11760 32493283
Cardiac arrest 21.81 16.11 65 8418 96711 32408332
Poisoning 21.47 16.11 20 8463 11138 32493905
Febrile neutropenia 21.22 16.11 3 8480 119563 32385480
Toxic cardiomyopathy 20.94 16.11 6 8477 255 32504788
Suicide attempt 20.21 16.11 36 8447 38208 32466835
Movement disorder 19.81 16.11 19 8464 10972 32494071
Electrocardiogram QRS complex prolonged 19.25 16.11 13 8470 4561 32500482
Soft tissue swelling 19.20 16.11 6 8477 344 32504699
Wrong patient received product 18.10 16.11 10 8473 2452 32502591
Acute kidney injury 17.66 16.11 31 8452 293437 32211606
Crime 17.58 16.11 4 8479 66 32504977
Pollakiuria 17.52 16.11 23 8460 18721 32486322
Congestive hepatopathy 17.41 16.11 9 8474 1931 32503112
Hypopnoea 17.40 16.11 8 8475 1332 32503711
Cardiac aneurysm 16.67 16.11 7 8476 938 32504105
Restlessness 16.59 16.11 26 8457 24855 32480188
Pruritus 16.59 16.11 72 8411 128630 32376413

Pharmacologic Action:

SourceCodeDescription
ATC D04AX01 DERMATOLOGICALS
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
Other antipruritics
ATC N06AA12 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Non-selective monoamine reuptake inhibitors
CHEBI has role CHEBI:35469 thymoanaleptics
MeSH PA D000928 Antidepressive Agents
MeSH PA D000929 Antidepressive Agents, Tricyclic
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D018494 Histamine Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006993 Hypnotics and Sedatives
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D000068776 Sleep Aids, Pharmaceutical
FDA EPC N0000175752 Tricyclic Antidepressant

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Atopic dermatitis indication 24079001 DOID:3310
Depressive disorder indication 35489007
Anxiety indication 48694002
Lichen simplex chronicus indication 53891004
Severe major depression with psychotic features indication 73867007
Bipolar affective disorder, current episode depression indication 191627008 DOID:3312
Insomnia indication 193462001
Itching of skin indication 418363000
Cholestatic pruritus off-label use 707150004
Suicidal thoughts contraindication 6471006
Alcoholism contraindication 7200002
Orthostatic hypotension contraindication 28651003
Torsades de pointes contraindication 31722008
Hyperthyroidism contraindication 34486009 DOID:7998
Conduction disorder of the heart contraindication 44808001
Hepatic failure contraindication 59927004
Sleep apnea contraindication 73430006 DOID:0050847
Chronic idiopathic constipation contraindication 82934008
Open-angle glaucoma contraindication 84494001 DOID:1067
Epilepsy contraindication 84757009 DOID:1826
Prolonged QT interval contraindication 111975006
Bipolar affective disorder, current episode manic contraindication 191618007
Sleep automatism contraindication 247962006
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Syncope contraindication 271594007
Angle-closure glaucoma contraindication 392291006 DOID:13550
Breastfeeding (mother) contraindication 413712001
Myocardial infarction in recovery phase contraindication 418044006
Congenital long QT syndrome contraindication 442917000

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.66 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 3MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 10238620 May 18, 2027 TREATMENT OF INSOMNIA
EQ 3MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 10653662 May 18, 2027 TREATMENT OF INSOMNIA
EQ 3MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 9486437 May 18, 2027 TREATMENT OF INSOMNIA
EQ 3MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 9861607 May 18, 2027 TREATMENT OF INSOMNIA
EQ 6MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 10238620 May 18, 2027 TREATMENT OF INSOMNIA
EQ 6MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 10653662 May 18, 2027 TREATMENT OF INSOMNIA
EQ 6MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 9486437 May 18, 2027 TREATMENT OF INSOMNIA
EQ 6MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 9861607 May 18, 2027 TREATMENT OF INSOMNIA
EQ 3MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 10653660 July 20, 2027 TREATMENT OF INSOMNIA
EQ 3MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 11110074 July 20, 2027 TREATMENT OF INSOMNIA
EQ 3MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 9572814 July 20, 2027 TREATMENT OF INSOMNIA
EQ 6MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 10653660 July 20, 2027 TREATMENT OF INSOMNIA
EQ 6MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 11110074 July 20, 2027 TREATMENT OF INSOMNIA
EQ 6MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 9572814 July 20, 2027 TREATMENT OF INSOMNIA
EQ 3MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 7915307 Aug. 24, 2027 TREATMENT OF INSOMNIA
EQ 6MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 7915307 Aug. 24, 2027 TREATMENT OF INSOMNIA
EQ 3MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 11234954 Jan. 18, 2028 TREATMENT OF INSOMNIA
EQ 6MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 11234954 Jan. 18, 2028 TREATMENT OF INSOMNIA
EQ 3MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 10548871 April 11, 2028 TREATMENT OF INSOMNIA
EQ 3MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 11096920 April 11, 2028 TREATMENT OF INSOMNIA
EQ 6MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 10548871 April 11, 2028 TREATMENT OF INSOMNIA
EQ 6MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 11096920 April 11, 2028 TREATMENT OF INSOMNIA
EQ 3MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 9107898 May 1, 2028 TREATMENT OF INSOMNIA
EQ 6MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 9107898 May 1, 2028 TREATMENT OF INSOMNIA
EQ 3MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 8513299 Sept. 7, 2030 TREATMENT OF INSOMNIA
EQ 6MG BASE SILENOR CURRAX N022036 March 17, 2010 RX TABLET ORAL 8513299 Sept. 7, 2030 TREATMENT OF INSOMNIA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium-dependent noradrenaline transporter Transporter INHIBITOR Kd 7.53 WOMBAT-PK CHEMBL
Histamine H1 receptor GPCR ANTAGONIST Ki 9.75 WOMBAT-PK DRUG LABEL
Alpha-2A adrenergic receptor GPCR Ki 6.30 DRUG MATRIX
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 6.58 DRUG MATRIX
Sodium-dependent serotonin transporter Transporter INHIBITOR Kd 7.17 WOMBAT-PK
5-hydroxytryptamine receptor 1A GPCR Ki 6.54 WOMBAT-PK
5-hydroxytryptamine receptor 2A GPCR EC50 7.45 WOMBAT-PK
5-hydroxytryptamine receptor 2B GPCR EC50 7.20 WOMBAT-PK
5-hydroxytryptamine receptor 2C GPCR EC50 7 WOMBAT-PK
5-hydroxytryptamine receptor 6 GPCR Ki 6.98 CHEMBL
5-hydroxytryptamine receptor 7 GPCR WOMBAT-PK
Alpha-1A adrenergic receptor GPCR Ki 7.63 WOMBAT-PK
Alpha-2B adrenergic receptor GPCR IC50 7.21 WOMBAT-PK
D(3) dopamine receptor GPCR Ki 6.33 DRUG MATRIX
D(1A) dopamine receptor GPCR EC50 6.50 WOMBAT-PK
Histamine H4 receptor GPCR EC50 6.79 WOMBAT-PK
Muscarinic acetylcholine receptor M1 GPCR Ki 7.42 WOMBAT-PK
Muscarinic acetylcholine receptor M2 GPCR Ki 6.80 WOMBAT-PK
Muscarinic acetylcholine receptor M3 GPCR Ki 7.28 WOMBAT-PK
Muscarinic acetylcholine receptor M4 GPCR Ki 7.09 WOMBAT-PK
Muscarinic acetylcholine receptor M5 GPCR Ki 7.13 WOMBAT-PK
Alpha-2C adrenergic receptor GPCR IC50 7 WOMBAT-PK
Alpha-1D adrenergic receptor GPCR Ki 7.37 DRUG MATRIX
Solute carrier family 22 member 1 Transporter IC50 4.95 CHEMBL
Solute carrier family 22 member 2 Transporter IC50 4.89 WOMBAT-PK
Histamine H2 receptor GPCR Ki 5.74 DRUG MATRIX
D(2) dopamine receptor GPCR EC50 6.50 WOMBAT-PK
Alpha-1B adrenergic receptor GPCR Ki 7.48 DRUG MATRIX
Alpha-1A adrenergic receptor GPCR IC50 11 CHEMBL
Serotonin (5-HT) receptor GPCR IC50 6.70 CHEMBL

External reference:

IDSource
4019736 VUID
N0000147828 NUI
D00814 KEGG_DRUG
1229-29-4 SECONDARY_CAS_RN
4017851 VANDF
4019736 VANDF
C0013085 UMLSCUI
CHEBI:4710 CHEBI
CHEMBL1628227 ChEMBL_ID
CHEMBL1628234 ChEMBL_ID
DB01142 DRUGBANK_ID
D004316 MESH_DESCRIPTOR_UI
667477 PUBCHEM_CID
1225 IUPHAR_LIGAND_ID
1855 INN_ID
5ASJ6HUZ7D UNII
203179 RXNORM
172015 MMSL
239355 MMSL
27123 MMSL
278670 MMSL
3183 MMSL
4638 MMSL
d00217 MMSL
001509 NDDF
004607 NDDF
11841005 SNOMEDCT_US
372587005 SNOMEDCT_US
85037008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Doxepin HUMAN PRESCRIPTION DRUG LABEL 1 0228-3315 TABLET, FILM COATED 3 mg ORAL ANDA 31 sections
Doxepin HUMAN PRESCRIPTION DRUG LABEL 1 0228-3316 TABLET, FILM COATED 6 mg ORAL ANDA 31 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-1049 CAPSULE 10 mg ORAL ANDA 17 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-3125 CAPSULE 25 mg ORAL ANDA 17 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-4250 CAPSULE 50 mg ORAL ANDA 17 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-4810 TABLET 3 mg ORAL NDA authorized generic 32 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-4811 TABLET 6 mg ORAL NDA authorized generic 32 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-5375 CAPSULE 75 mg ORAL ANDA 17 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-5390 TABLET 3 mg ORAL ANDA 34 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-5391 TABLET 6 mg ORAL ANDA 34 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-6410 CAPSULE 100 mg ORAL ANDA 17 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-8117 CREAM 50 mg TOPICAL NDA authorized generic 18 sections
Zonalon HUMAN PRESCRIPTION DRUG LABEL 1 0378-8123 CREAM 50 mg TOPICAL NDA 19 sections
PRUDOXIN HUMAN PRESCRIPTION DRUG LABEL 1 0378-8130 CREAM 50 mg TOPICAL NDA 18 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-4062 CAPSULE 10 mg ORAL ANDA 15 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-4063 CAPSULE 25 mg ORAL ANDA 15 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-4064 CAPSULE 50 mg ORAL ANDA 15 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-4065 CAPSULE 75 mg ORAL ANDA 15 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-4066 CAPSULE 100 mg ORAL ANDA 15 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6970 CAPSULE 10 mg ORAL ANDA 16 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6971 CAPSULE 25 mg ORAL ANDA 16 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6972 CAPSULE 50 mg ORAL ANDA 16 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6973 CAPSULE 100 mg ORAL ANDA 16 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7052 CAPSULE 10 mg ORAL ANDA 16 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7053 CAPSULE 25 mg ORAL ANDA 16 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7054 CAPSULE 50 mg ORAL ANDA 16 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7055 CAPSULE 100 mg ORAL ANDA 16 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10267-5059 CAPSULE 10 mg ORAL ANDA 15 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10267-5060 CAPSULE 25 mg ORAL ANDA 15 sections
Doxepin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10267-5061 CAPSULE 50 mg ORAL ANDA 15 sections