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

Stem definition	Drug id	CAS RN
diazepam derivatives	2585	846-50-4

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
20	mg	O

ADMET properties:

Property	Value	Reference
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 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	91 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
Feb. 27, 1981	FDA	MALLINCKRODT INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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)

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
GABA-A receptor alpha-1/beta-2/gamma-2	Ion channel	P14867 P18507 P47870	GBRA1_HUMAN GBRB2_HUMAN GBRG2_HUMAN	POSITIVE ALLOSTERIC MODULATOR				WOMBAT-PK	CHEMBL
Nuclear receptor subfamily 1 group I member 3	Nuclear hormone receptor	Q14994	NR1I3_HUMAN					WOMBAT-PK

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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