Oxazepam

Overview

Oxazepam is an intermediate-acting, 3-hydroxybenzodiazepine used in the treatment of alcohol withdrawal and anxiety disorders. Oxazepam, like related 3-hydroxybenzodiazepine lorazepam, is considered less susceptible to pharmacokinetic variability based on patient-specific factors (e.g. age, liver disease) - this feature is advantageous as compared to other benzodiazepines, and is likely owing in part to oxazepam's relatively simple metabolism. It is an active metabolite of both diazepam and temazepam and undergoes very little biotransformation following absorption, making it unlikely to participate in pharmacokinetic interactions.

Indication

Oxazepam is indicated for the management of anxiety disorders and for the short-term relief of symptoms of anxiety. It may also be used in the management of alcohol withdrawal symptoms.

Associated Conditions

Alcohol Withdrawal Syndrome
Anxiety
Anxiety Disorders

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Pharmacovigilance in Gerontopsychiatric Patients	2015/03/02	NCT02374567	Phase 3	Terminated	Hannover Medical School
Study to Evaluate the Presence of a Hangover Effect in Healthy Adults After Administration of Songha® Night Tablets	2014/10/24	NCT02273453	Phase 1	Completed	Boehringer Ingelheim
Comparative Study of Gamma-hydroxy Butyrate Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome	2014/03/18	NCT02090504	Phase 4	Completed	Catholic University of the Sacred Heart
A Placebo-Controlled Study of a Combination of Metyrapone and Oxazepam in Cocaine Addiction	2007/12/05	NCT00567814	Not Applicable	Completed	Embera NeuroTherapeutics, Inc.
The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient	2001/08/31	NCT00000661	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Oxazepam	Actavis Pharma, Inc.	0228-2067	ORAL	10 mg in 1 1	1/12/2024
Oxazepam	American Health Packaging	62584-812	ORAL	10 mg in 1 1	12/2/2023
Oxazepam	Aphena Pharma Solutions - Tennessee, Inc.	43353-074	ORAL	30 mg in 1 1	4/6/2012
Oxazepam	Aphena Pharma Solutions - Tennessee, LLC	67544-117	ORAL	10 mg in 1 1	3/31/2014
OXAZEPAM	STAT RX USA LLC	16590-304	ORAL	15 mg in 1 1	12/15/2009
Oxazepam	Actavis Pharma, Inc.	0228-2069	ORAL	15 mg in 1 1	1/12/2024
Oxazepam	TruPharma, LLC	52817-290	ORAL	10 mg in 1 1	3/3/2021
Oxazepam	American Health Packaging	62584-813	ORAL	15 mg in 1 1	12/2/2023
Oxazepam	Aphena Pharma Solutions - Tennessee, LLC	43353-965	ORAL	10 mg in 1 1	12/16/2014
Oxazepam	TruPharma, LLC	52817-292	ORAL	30 mg in 1 1	3/3/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
MURELAX Oxazepam 15mg tablet	75122	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/20/2000
ALEPAM 30 oxazepam 30mg tablet blister pack	385082	Alphapharm Pty Ltd	Medicine	A	7/12/2022
MURELAX Oxazepam 30mg tablet	12952	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/19/1991
ALEPAM 15 oxazepam 15mg tablet lister pack	385081	Alphapharm Pty Ltd	Medicine	A	7/12/2022
SEREPAX oxazepam 30 mg tablet blister pack	10417	Aspen Pharmacare Australia Pty Ltd	Medicine	A	7/4/1991
SEREPAX oxazepam 15 mg tablet blister pack	174675	Aspen Pharmacare Australia Pty Ltd	Medicine	A	11/23/2010
APO-OXAZEPAM oxazepam 30mg tablet	163213	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/12/2010
OXAZEPAM-WGR Oxazepam 30 mg tablet blister pack	423290	GM Pharma International Pty Ltd	Medicine	A	1/3/2024
OXAZEPAM MYLAN oxazepam 30mg tablet bottle	369611	Bafna Pharmaceuticals Pty Ltd	Medicine	A	10/11/2021
OXAZEPAM MYLAN oxazepam 15mg tablet bottle	369610	Bafna Pharmaceuticals Pty Ltd	Medicine	A	10/11/2021

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PMS-OXAZEPAM TAB 15MG	Pharmascience Inc	00726370	Tablet - Oral	15 MG	12/31/1989
NOVOXAPAM TAB 15MG	novopharm limited	00496529	Tablet - Oral	15 MG	12/31/1982
OXPAM	biomed pharma	00414247	Tablet - Oral	10 MG	12/31/1979
RIVA-OXAZEPAM	laboratoire riva inc.	00568392	Tablet - Oral	10 MG	12/31/1983
BIO-OXAZEPAM	biomed pharma	02247178	Tablet - Oral	15 MG	4/23/2003
BIO-OXAZEPAM	biomed pharma	02247179	Tablet - Oral	30 MG	4/23/2003
RIVA-OXAZEPAM	laboratoire riva inc.	00568406	Tablet - Oral	15 MG	12/31/1983
NOVOXAPAM TAB 30MG	novopharm limited	00496537	Tablet - Oral	30 MG	12/31/1982
OXAZEPAM TABLETS 15MG	d.c. labs limited	00483915	Tablet - Oral	15 MG	12/31/1980
APO-OXAZEPAM	Apotex Inc	00402737	Tablet - Oral	30 MG	12/31/1979

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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