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

Stem definitionDrug idCAS RN
diazepam derivatives 2585 846-50-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • temazepam
  • (RS)-Temazepam
  • levanxene
  • levanxol
A benzodiazepine that acts as a GAMMA-AMINOBUTYRIC ACID modulator and anti-anxiety agent.
  • Molecular weight: 300.74
  • Formula: C16H13ClN2O2
  • CLOGP: 2.34
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 52.90
  • ALOGS: -3.75
  • ROTB: 1

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
20 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.60 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.83 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 91 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Feb. 27, 1981 FDA MALLINCKRODT INC

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 325.18 10.23 530 43372 145390 46496770
Toxicity to various agents 303.85 10.23 636 43266 211130 46431030
Temperature regulation disorder 165.75 10.23 75 43827 3285 46638875
Coeliac disease 137.32 10.23 85 43817 7076 46635084
Food allergy 117.23 10.23 76 43826 6857 46635303
Overdose 116.31 10.23 280 43622 101699 46540461
Respiratory arrest 82.16 10.23 128 43774 33688 46608472
Immunodeficiency 80.15 10.23 79 43823 13027 46629133
Myocardial depression 78.40 10.23 26 43876 482 46641678
Bursitis 70.33 10.23 90 43812 19752 46622408
Decorticate posture 66.02 10.23 21 43881 339 46641821
Drug ineffective 62.68 10.23 378 43524 677460 45964700
Off label use 59.89 10.23 172 43730 379669 46262491
Hyperhidrosis 59.43 10.23 202 43700 89106 46553054
Maternal exposure during pregnancy 55.49 10.23 14 43888 102535 46539625
Poisoning 55.24 10.23 67 43835 13927 46628233
Accidental overdose 54.47 10.23 80 43822 19986 46622174
Cardiac arrest 47.95 10.23 190 43712 90209 46551951
Rash erythematous 47.64 10.23 102 43800 34248 46607912
Fluid retention 46.60 10.23 129 43773 50917 46591243
Drug intolerance 44.00 10.23 44 43858 147005 46495155
Insomnia 43.70 10.23 285 43617 164639 46477521
Exposure during pregnancy 43.16 10.23 24 43878 108188 46533972
Drug abuse 42.67 10.23 144 43758 63264 46578896
Constipation 42.62 10.23 295 43607 173802 46468358
Synovitis 40.26 10.23 5 43897 61070 46581090
Impaired reasoning 37.01 10.23 9 43893 49 46642111
Hypothermia 33.68 10.23 49 43853 12134 46630026
Cardio-respiratory arrest 33.49 10.23 128 43774 59741 46582419
Amblyopia 32.30 10.23 11 43891 222 46641938
Infected dermal cyst 31.56 10.23 13 43889 451 46641709
Coma scale abnormal 28.44 10.23 29 43873 4977 46637183
Back pain 28.31 10.23 312 43590 209727 46432433
Substance abuse 27.13 10.23 26 43876 4141 46638019
Judgement impaired 27.04 10.23 13 43889 654 46641506
Transplant dysfunction 26.38 10.23 27 43875 4655 46637505
Band neutrophil percentage increased 25.57 10.23 9 43893 201 46641959
Suicidal ideation 25.57 10.23 113 43789 56269 46585891
Respiratory depression 25.54 10.23 42 43860 11558 46630602
Thiopurine methyltransferase decreased 25.16 10.23 10 43892 316 46641844
Anxiety 24.84 10.23 271 43631 181686 46460474
Infusion related reaction 24.21 10.23 36 43866 101172 46540988
Intentional overdose 23.54 10.23 122 43780 64822 46577338
Toxicologic test abnormal 23.51 10.23 12 43890 687 46641473
Myelocyte percentage increased 23.37 10.23 8 43894 164 46641996
Treatment failure 23.37 10.23 32 43870 93055 46549105
Drug withdrawal syndrome 22.84 10.23 67 43835 27317 46614843
Rash 22.73 10.23 220 43682 356292 46285868
Therapeutic product effect incomplete 22.66 10.23 24 43878 78129 46564031
Libido increased 22.39 10.23 12 43890 760 46641400
Hand deformity 22.37 10.23 3 43899 34571 46607589
Asthma 22.30 10.23 155 43747 91387 46550773
Urine oxalate increased 22.11 10.23 8 43894 194 46641966
Upper respiratory tract infection 22.07 10.23 118 43784 63438 46578722
Ventricular hypokinesia 22.04 10.23 23 43879 4055 46638105
Band neutrophil count increased 21.31 10.23 9 43893 333 46641827
Arthralgia 21.18 10.23 230 43672 364373 46277787
Hostility 20.77 10.23 14 43888 1348 46640812
Oesophagitis ulcerative 20.35 10.23 10 43892 528 46641632
Peripheral swelling 19.76 10.23 79 43823 157992 46484168
Somnambulism 19.69 10.23 24 43878 5013 46637147
Neutropenia 19.58 10.23 69 43833 143135 46499025
Apnoea 19.54 10.23 29 43873 7310 46634850
Retinal depigmentation 19.52 10.23 8 43894 274 46641886
Panic attack 19.31 10.23 52 43850 20190 46621970
Suspected product quality issue 19.26 10.23 7 43895 172 46641988
Poisoning deliberate 19.24 10.23 30 43872 7896 46634264
Homicide 19.02 10.23 9 43893 437 46641723
Analgesic drug level above therapeutic 18.75 10.23 7 43895 186 46641974
Withdrawal syndrome 18.74 10.23 48 43854 18086 46624074
Interstitial lung disease 18.72 10.23 14 43888 53935 46588225
Arthropathy 18.49 10.23 32 43870 84668 46557492
Hepatocellular injury 18.09 10.23 3 43899 29519 46612641
Mental disorder 17.88 10.23 54 43848 22371 46619789
Myelocyte count increased 17.66 10.23 8 43894 351 46641809
Abdominal discomfort 17.38 10.23 78 43824 151087 46491073
Injection site erythema 17.29 10.23 27 43875 74400 46567760
Atrioventricular block first degree 17.27 10.23 25 43877 6161 46635999
Acute kidney injury 17.00 10.23 141 43761 235714 46406446
Depression 16.60 10.23 238 43664 169866 46472294
Pulmonary congestion 16.16 10.23 40 43862 14759 46627401
Tremor 16.12 10.23 173 43729 115466 46526694
Glossodynia 16.07 10.23 11 43891 44362 46597798
Specific gravity urine decreased 16.02 10.23 8 43894 437 46641723
Systemic lupus erythematosus 15.77 10.23 23 43879 65157 46577003
Hypovolaemia 15.63 10.23 31 43871 9857 46632303
Abortion spontaneous 15.57 10.23 11 43891 43635 46598525
Joint swelling 15.53 10.23 92 43810 165981 46476179
Suspected counterfeit product 15.23 10.23 7 43895 318 46641842
Abnormal behaviour 15.21 10.23 49 43853 21009 46621151
Homicidal ideation 15.18 10.23 13 43889 1789 46640371
Unresponsive to stimuli 14.98 10.23 65 43837 32109 46610051
Sternal fracture 14.78 10.23 12 43890 1534 46640626
Upper respiratory tract congestion 14.69 10.23 13 43889 1870 46640290
Depressed mood 14.52 10.23 66 43836 33253 46608907
Bruxism 14.52 10.23 16 43886 3001 46639159
Victim of sexual abuse 14.46 10.23 8 43894 540 46641620
Akathisia 14.45 10.23 26 43876 7688 46634472
Ovarian cyst 14.26 10.23 37 43865 14050 46628110
Amnesia 14.25 10.23 77 43825 41554 46600606
Monocyte percentage increased 14.20 10.23 10 43892 1033 46641127
Calculus urethral 14.02 10.23 3 43899 8 46642152
Swelling 13.86 10.23 65 43837 124446 46517714
C-reactive protein increased 13.85 10.23 21 43881 58569 46583591
Post-traumatic neck syndrome 13.80 10.23 11 43891 1370 46640790
Drug hypersensitivity 13.27 10.23 156 43746 243669 46398491
Postmortem blood drug level increased 13.14 10.23 7 43895 438 46641722
Soft tissue injury 13.04 10.23 9 43893 900 46641260
Leukopenia 13.02 10.23 28 43874 68315 46573845
Rheumatoid arthritis 12.95 10.23 154 43748 240061 46402099
Urticaria 12.86 10.23 62 43840 117830 46524330
Mood swings 12.83 10.23 39 43863 16213 46625947
Sensitisation 12.67 10.23 8 43894 689 46641471
Febrile neutropenia 12.65 10.23 46 43856 94581 46547579
Bacterial test 12.64 10.23 10 43892 1233 46640927
Wound 12.57 10.23 13 43889 42789 46599371
Hyperthermia 12.52 10.23 25 43877 7989 46634171
Peptic ulcer perforation 12.38 10.23 5 43897 165 46641995
Arteriosclerosis coronary artery 12.21 10.23 25 43877 8131 46634029
Clonus 12.15 10.23 17 43885 4063 46638097
Suicide attempt 12.13 10.23 91 43811 54945 46587215
Distributive shock 12.11 10.23 7 43895 514 46641646
Foetal exposure during pregnancy 11.99 10.23 7 43895 30740 46611420
Thrombocytopenia 11.90 10.23 70 43832 126511 46515649
Somnolence 11.87 10.23 210 43692 156311 46485849
Duodenal ulcer 11.86 10.23 23 43879 7195 46634965
Septic shock 11.64 10.23 23 43879 57870 46584290
Transplant rejection 11.62 10.23 27 43875 9569 46632591
Subendocardial ischaemia 11.55 10.23 4 43898 85 46642075
Poor quality sleep 11.48 10.23 36 43866 15217 46626943
Rectal polyp 11.46 10.23 8 43894 815 46641345
Monoplegia 11.43 10.23 13 43889 2523 46639637
General physical health deterioration 11.43 10.23 63 43839 115706 46526454
Arteriosclerosis 11.37 10.23 27 43875 9706 46632454
Dilatation atrial 11.36 10.23 12 43890 2145 46640015
Loss of consciousness 11.18 10.23 153 43749 108085 46534075
Drug reaction with eosinophilia and systemic symptoms 11.14 10.23 7 43895 29541 46612619
Accidental death 11.10 10.23 11 43891 1824 46640336
Vitamin B1 deficiency 10.92 10.23 5 43897 225 46641935
Acquired immunodeficiency syndrome 10.91 10.23 4 43898 101 46642059
Abdominal pain upper 10.85 10.23 86 43816 145219 46496941
Personality disorder 10.77 10.23 14 43888 3119 46639041
Lung disorder 10.75 10.23 15 43887 43289 46598871
Psoriatic arthropathy 10.74 10.23 11 43891 36368 46605792
Dystrophic calcification 10.69 10.23 4 43898 107 46642053
Cholestasis 10.66 10.23 6 43896 26887 46615273
Nasopharyngitis 10.66 10.23 93 43809 153905 46488255
Renal infarct 10.64 10.23 9 43893 1218 46640942
No adverse event 10.51 10.23 10 43892 34221 46607939
Herpes zoster 10.45 10.23 31 43871 67841 46574319

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
Toxicity to various agents 542.34 11.12 706 24715 176477 29750580
Completed suicide 316.45 11.12 405 25016 99087 29827970
Overdose 75.36 11.12 198 25223 84139 29842918
Drug abuse 71.61 11.12 191 25230 81881 29845176
Accidental overdose 52.58 11.12 71 25350 18204 29908853
Poisoning 48.63 11.12 54 25367 11328 29915729
Off label use 48.47 11.12 86 25335 249204 29677853
Dysarthria 36.23 11.12 80 25341 30410 29896647
Dystonic tremor 35.81 11.12 10 25411 112 29926945
Injury 31.65 11.12 62 25359 21669 29905388
Pulmonary congestion 31.25 11.12 45 25376 12242 29914815
Insomnia 30.43 11.12 158 25263 93178 29833879
Anxiety 29.89 11.12 153 25268 89718 29837339
Depressed level of consciousness 28.41 11.12 84 25337 38138 29888919
Logorrhoea 27.90 11.12 19 25402 2063 29924994
Suicidal ideation 26.49 11.12 79 25342 36035 29891022
Product use in unapproved indication 26.17 11.12 15 25406 73678 29853379
Accidental poisoning 25.15 11.12 11 25410 493 29926564
Drug withdrawal syndrome 24.69 11.12 53 25368 19756 29907301
Crystalluria 24.59 11.12 10 25411 373 29926684
Suicide attempt 23.88 11.12 77 25344 36620 29890437
Abnormal behaviour 22.67 11.12 60 25361 25563 29901494
Mesothelioma 22.58 11.12 10 25411 462 29926595
Congestive hepatopathy 22.30 11.12 16 25405 1888 29925169
Nonalcoholic fatty liver disease 22.11 11.12 7 25414 124 29926933
Coordination abnormal 21.95 11.12 29 25392 7276 29919781
Depression 21.59 11.12 141 25280 90296 29836761
Respiratory depression 20.75 11.12 36 25385 11467 29915590
Drug abuser 20.75 11.12 22 25399 4379 29922678
Homicide 20.14 11.12 12 25409 1034 29926023
Drug dependence 20.00 11.12 51 25370 21244 29905813
Aggression 19.28 11.12 72 25349 36835 29890222
Somnambulism 18.70 11.12 18 25403 3196 29923861
Depersonalisation/derealisation disorder 18.47 11.12 9 25412 518 29926539
Lethargy 18.13 11.12 74 25347 39445 29887612
Mental disorder 17.94 11.12 37 25384 13412 29913645
Interstitial lung disease 17.73 11.12 15 25406 60182 29866875
Conduction disorder 17.55 11.12 14 25407 1937 29925120
Febrile neutropenia 17.11 11.12 41 25380 106652 29820405
Substance abuse 16.77 11.12 25 25396 7015 29920042
Accidental death 16.76 11.12 14 25407 2065 29924992
Sexually transmitted disease 16.67 11.12 4 25417 23 29927034
Victim of crime 16.61 11.12 7 25414 286 29926771
Contraindication to medical treatment 16.15 11.12 8 25413 477 29926580
Unresponsive to stimuli 15.90 11.12 54 25367 26365 29900692
Drug screen positive 15.63 11.12 19 25402 4388 29922669
Sexually inappropriate behaviour 15.61 11.12 7 25414 333 29926724
Poisoning deliberate 15.56 11.12 22 25399 5882 29921175
Foetal exposure during pregnancy 15.40 11.12 6 25415 36865 29890192
Osmolar gap abnormal 15.11 11.12 4 25417 36 29927021
Psychotic disorder 14.78 11.12 46 25375 21469 29905588
Tangentiality 14.57 11.12 5 25416 115 29926942
Breast cancer male 14.48 11.12 6 25415 235 29926822
Drug ineffective 14.41 11.12 203 25218 340184 29586873
Hepatic function abnormal 14.24 11.12 9 25412 41936 29885121
Sedation 14.14 11.12 38 25383 16335 29910722
General physical health deterioration 14.05 11.12 41 25380 99903 29827154
Treatment failure 13.90 11.12 6 25415 34673 29892384
Blood disorder 13.83 11.12 15 25406 3064 29923993
Cerebral arteriovenous malformation haemorrhagic 13.64 11.12 4 25417 54 29927003
Cardiomegaly 12.86 11.12 34 25387 14475 29912582
Fear 12.40 11.12 28 25393 10797 29916260
Dysprosody 12.40 11.12 3 25418 18 29927039
Adjustment disorder 12.25 11.12 8 25413 810 29926247
Exposure via ingestion 12.22 11.12 13 25408 2598 29924459
Emotional distress 12.05 11.12 35 25386 15730 29911327
Emotional disorder 12.00 11.12 18 25403 5076 29921981
Neck injury 11.96 11.12 9 25412 1143 29925914
Accident 11.88 11.12 15 25406 3598 29923459
Nervousness 11.88 11.12 29 25392 11759 29915298
Borderline personality disorder 11.79 11.12 6 25415 379 29926678
Obsessive-compulsive disorder 11.77 11.12 16 25405 4125 29922932
Alcohol poisoning 11.40 11.12 15 25406 3749 29923308
Pulmonary oedema 11.37 11.12 70 25351 43905 29883152
Intentional self-injury 11.27 11.12 31 25390 13501 29913556
Behaviour disorder 11.27 11.12 12 25409 2400 29924657
Ventricular hypertrophy 11.13 11.12 17 25404 4870 29922187

Pharmacologic Action:

SourceCodeDescription
ATC N05CD07 NERVOUS SYSTEM
PSYCHOLEPTICS
HYPNOTICS AND SEDATIVES
Benzodiazepine derivatives
FDA CS M0002356 Benzodiazepines
FDA EPC N0000175694 Benzodiazepine
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D018682 GABA Agents
MeSH PA D018757 GABA Modulators
MeSH PA D006993 Hypnotics and Sedatives
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D014149 Tranquilizing Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Insomnia indication 193462001
Suicidal thoughts contraindication 6471006
Alcohol intoxication contraindication 25702006
Depressive disorder contraindication 35489007
Substance abuse contraindication 66214007
Sleep apnea contraindication 73430006 DOID:0050847
Kidney disease contraindication 90708001 DOID:557
Hypoalbuminemia contraindication 119247004
Disease of liver contraindication 235856003 DOID:409
Sleep automatism contraindication 247962006
Pregnancy, function contraindication 289908002
Severe chronic obstructive pulmonary disease contraindication 313299006
Memory impairment contraindication 386807006
Chronic lung disease contraindication 413839001

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.07 acidic
pKa2 1.46 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
GABA-A receptor alpha-1/beta-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR WOMBAT-PK CHEMBL
Nuclear receptor subfamily 1 group I member 3 Nuclear hormone receptor WOMBAT-PK

External reference:

IDSource
4017894 VUID
N0000146246 NUI
D00370 KEGG_DRUG
4017894 VANDF
C0699555 UMLSCUI
CHEBI:9435 CHEBI
CHEMBL967 ChEMBL_ID
D013693 MESH_DESCRIPTOR_UI
2753 INN_ID
DB00231 DRUGBANK_ID
CHB1QD2QSS UNII
5391 PUBCHEM_CID
7300 IUPHAR_LIGAND_ID
10355 RXNORM
2322 MMSL
5544 MMSL
d00384 MMSL
001450 NDDF
387300007 SNOMEDCT_US
54705000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 0228-2076 CAPSULE 15 mg ORAL ANDA 19 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 0228-2077 CAPSULE 30 mg ORAL ANDA 19 sections
RESTORIL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9914 CAPSULE 22.50 mg ORAL NDA 26 sections
RESTORIL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9915 CAPSULE 7.50 mg ORAL NDA 26 sections
RESTORIL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9916 CAPSULE 15 mg ORAL NDA 26 sections
RESTORIL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9917 CAPSULE 30 mg ORAL NDA 26 sections
TEMAZEPAM HUMAN PRESCRIPTION DRUG LABEL 1 0406-9959 CAPSULE 22.50 mg ORAL NDA 26 sections
TEMAZEPAM HUMAN PRESCRIPTION DRUG LABEL 1 0406-9960 CAPSULE 7.50 mg ORAL NDA 26 sections
TEMAZEPAM HUMAN PRESCRIPTION DRUG LABEL 1 0406-9961 CAPSULE 15 mg ORAL NDA 26 sections
TEMAZEPAM HUMAN PRESCRIPTION DRUG LABEL 1 0406-9962 CAPSULE 30 mg ORAL NDA 26 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 0615-7808 CAPSULE 15 mg ORAL ANDA 27 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 0615-7809 CAPSULE 30 mg ORAL ANDA 27 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 0904-6436 CAPSULE 7.50 mg ORAL ANDA 24 sections
TEMAZEPAM HUMAN PRESCRIPTION DRUG LABEL 1 16590-214 CAPSULE 15 mg ORAL ANDA 14 sections
temazepam Human Prescription Drug Label 1 17856-0148 CAPSULE 15 mg ORAL ANDA 23 sections
temazepam HUMAN PRESCRIPTION DRUG LABEL 1 21695-282 CAPSULE 15 mg ORAL ANDA 24 sections
temazepam HUMAN PRESCRIPTION DRUG LABEL 1 21695-283 CAPSULE 30 mg ORAL ANDA 24 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 33261-101 CAPSULE 15 mg ORAL ANDA 23 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 33261-102 CAPSULE 30 mg ORAL ANDA 23 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 33358-332 CAPSULE 15 mg ORAL ANDA 18 sections
temazepam HUMAN PRESCRIPTION DRUG LABEL 1 35356-663 CAPSULE 30 mg ORAL ANDA 23 sections
temazepam HUMAN PRESCRIPTION DRUG LABEL 1 35356-664 CAPSULE 15 mg ORAL ANDA 23 sections
temazepam HUMAN PRESCRIPTION DRUG LABEL 1 35356-821 CAPSULE 22.50 mg ORAL ANDA 23 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 40032-120 CAPSULE 7.50 mg ORAL ANDA 17 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 40032-121 CAPSULE 15 mg ORAL ANDA 17 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 40032-122 CAPSULE 22.50 mg ORAL ANDA 17 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 40032-123 CAPSULE 30 mg ORAL ANDA 17 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 42291-797 CAPSULE 7.50 mg ORAL ANDA 26 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 42549-561 CAPSULE 30 mg ORAL ANDA 21 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 42549-651 CAPSULE 15 mg ORAL ANDA 21 sections