Oxazepam Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actavis Elizabeth Llc (2012-03-02)
Oldest Current Product
1988-04-14
License(s)
ANDA
RxNORM
ORAL CAPSULE\OXAZEPAM
FDAOB
ORAL\CAPSULE\OXAZEPAM
ORAL\TABLET\OXAZEPAM
SPL Active
ORAL\CAPSULE, GELATIN COATED\OXAZEPAM
ORAL\CAPSULE\OXAZEPAM
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\OXAZEPAM
ORAL\CAPSULE\OXAZEPAM

product(s) by strength(s)

oxazepam 10 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002282067ANDAActavis Elizabeth Llc2007-01-02OXAZEPAMORALCAPSULE, GELATIN COATEDANDA072251a0d5a4c1-ec79-42e6-8e8f-ae4d144edb43
2007812809ANDASandoz Inc1988-04-19OXAZEPAMORALCAPSULEANDA071813140d8f61-912b-449a-9c34-b52e08b3d819

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490715ANDARemedyrepack Inc.2011-09-06OXAZEPAMORALCAPSULE007812809ANDA07181352488349-1c84-4cdc-89d1-c841a68e904f
2625840812ANDAAmerican Health Packaging2013-07-05OXAZEPAMORALCAPSULE002282067ANDA07225103440821-831c-4085-98f9-faa88e98c503
3675440117ANDAAphena Pharma Solutions - Tennessee, Inc.2007-01-02OXAZEPAMORALCAPSULE, GELATIN COATED002282067ANDA0722513bccbfa9-fdcf-44c3-86f5-028ca92223ca

oxazepam 15 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002282069ANDAActavis Elizabeth Llc2007-01-02OXAZEPAMORALCAPSULE, GELATIN COATEDANDA072252a0d5a4c1-ec79-42e6-8e8f-ae4d144edb43
2007812810ANDASandoz Inc1988-04-19OXAZEPAMORALCAPSULEANDA071756140d8f61-912b-449a-9c34-b52e08b3d819

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1636294298ANDABryant Ranch Prepack2011-01-06OXAZEPAMORALCAPSULE001724805ANDA070944e2ccffa0-039d-b77d-5b10-c3e485ab2b99

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900304ANDAStat Rx Usa Llc1988-04-14OXAZEPAMORALCAPSULE002282069ANDA072252a70c61ac-412c-4886-9c5e-7b7e5d84fbb5
2625840813ANDAAmerican Health Packaging2013-07-05OXAZEPAMORALCAPSULE002282069ANDA07225203440821-831c-4085-98f9-faa88e98c503
3675440268ANDAAphena Pharma Solutions - Tennessee, Inc.2007-01-02OXAZEPAMORALCAPSULE, GELATIN COATED002282069ANDA0722523bccbfa9-fdcf-44c3-86f5-028ca92223ca

oxazepam 30 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002282073ANDAActavis Elizabeth Llc2007-01-02OXAZEPAMORALCAPSULE, GELATIN COATEDANDA072253a0d5a4c1-ec79-42e6-8e8f-ae4d144edb43
2007812811ANDASandoz Inc1988-04-19OXAZEPAMORALCAPSULEANDA071814140d8f61-912b-449a-9c34-b52e08b3d819

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1433530074ANDAAphena Pharma Solutions - Tennessee, Llc2007-01-02OXAZEPAMORALCAPSULE, GELATIN COATED002282073ANDA0722538b11788c-2386-4c4a-a9b0-de2bdccbadaa
2625840814ANDAAmerican Health Packaging2013-07-05OXAZEPAMORALCAPSULE002282073ANDA07225303440821-831c-4085-98f9-faa88e98c503

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070640ZAXOPAMTrueQUANTUM PHARMICS LTD1988-03-01ANDA070640_001
2ANDA070641ZAXOPAMTrueQUANTUM PHARMICS LTD1988-03-01ANDA070641_001
3ANDA070650ZAXOPAMTrueQUANTUM PHARMICS LTD1988-03-01ANDA070650_001
4ANDA070943OXAZEPAMTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1987-08-03ANDA070943_001
5ANDA070944OXAZEPAMTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1987-08-03ANDA070944_001
6ANDA070945OXAZEPAMTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1987-08-03ANDA070945_001
7ANDA071026OXAZEPAMTrueMUTUAL PHARMACEUTICAL CO INC1987-08-10ANDA071026_001, ANDA071026_002, ANDA071026_003
8ANDA071713OXAZEPAMTrueMYLAN PHARMACEUTICALS INC1987-10-20ANDA071713_001
9ANDA071714OXAZEPAMTrueMYLAN PHARMACEUTICALS INC1987-10-20ANDA071714_001
10ANDA071715OXAZEPAMTrueMYLAN PHARMACEUTICALS INC1987-10-20ANDA071715_001
11ANDA071756OXAZEPAMSANDOZ INC1988-04-19ANDA071756_001
12ANDA071813OXAZEPAMSANDOZ INC1988-04-19ANDA071813_001
13ANDA071814OXAZEPAMSANDOZ INC1988-04-19ANDA071814_001
14ANDA071955OXAZEPAMTrueAMERICAN THERAPEUTICS INC1988-03-03ANDA071955_001
15ANDA071956OXAZEPAMTrueAMERICAN THERAPEUTICS INC1988-03-03ANDA071956_001
16ANDA071957OXAZEPAMTrueAMERICAN THERAPEUTICS INC1988-03-03ANDA071957_001
17ANDA072251OXAZEPAMACTAVIS ELIZABETH LLC1988-04-14ANDA072251_001
18ANDA072252OXAZEPAMACTAVIS ELIZABETH LLC1988-04-14ANDA072252_001
19ANDA072253OXAZEPAMACTAVIS ELIZABETH LLC1988-04-14ANDA072253_001
20ANDA072952OXAZEPAMTrueWATSON LABORATORIES INC1990-09-28ANDA072952_001
21ANDA072953OXAZEPAMTrueWATSON LABORATORIES INC1990-09-28ANDA072953_001
22ANDA072954OXAZEPAMTrueWATSON LABORATORIES INC1990-09-28ANDA072954_001
23NDA015539SERAXTrueALPHARMA US PHARMACEUTICALS DIVISIONNDA015539_002, NDA015539_004, NDA015539_006, NDA015539_008

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070640_001discontinuedOXAZEPAM (15MG)ORALCAPSULEFalse1988-03-01ZAXOPAM
2ANDA070641_001discontinuedOXAZEPAM (30MG)ORALCAPSULEFalse1988-03-01ZAXOPAM
3ANDA070650_001discontinuedOXAZEPAM (10MG)ORALCAPSULEFalse1988-03-01ZAXOPAM
4ANDA070943_001discontinuedOXAZEPAM (10MG)ORALCAPSULEFalse1987-08-03OXAZEPAM
5ANDA070944_001discontinuedOXAZEPAM (15MG)ORALCAPSULEFalse1987-08-03OXAZEPAM
6ANDA070945_001discontinuedOXAZEPAM (30MG)ORALCAPSULEFalse1987-08-03OXAZEPAM
7ANDA071026_001discontinuedOXAZEPAM (30MG)ORALCAPSULEFalse1987-08-10OXAZEPAM
8ANDA071026_002discontinuedOXAZEPAM (10MG)ORALCAPSULEFalse1987-08-10OXAZEPAM
9ANDA071026_003discontinuedOXAZEPAM (15MG)ORALCAPSULEFalse1987-08-10OXAZEPAM
10ANDA071713_001discontinuedOXAZEPAM (10MG)ORALCAPSULEFalse1987-10-20OXAZEPAM
11ANDA071714_001discontinuedOXAZEPAM (15MG)ORALCAPSULEFalse1987-10-20OXAZEPAM
12ANDA071715_001discontinuedOXAZEPAM (30MG)ORALCAPSULEFalse1987-10-20OXAZEPAM
13ANDA071756_001RXOXAZEPAM (15MG)ORALCAPSULEFalseAB1988-04-19OXAZEPAM
14ANDA071813_001RXOXAZEPAM (10MG)ORALCAPSULEFalseAB1988-04-19OXAZEPAM
15ANDA071814_001RXOXAZEPAM (30MG)ORALCAPSULEFalseAB1988-04-19OXAZEPAM
16ANDA071955_001discontinuedOXAZEPAM (10MG)ORALCAPSULEFalse1988-03-03OXAZEPAM
17ANDA071956_001discontinuedOXAZEPAM (15MG)ORALCAPSULEFalse1988-03-03OXAZEPAM
18ANDA071957_001discontinuedOXAZEPAM (30MG)ORALCAPSULEFalse1988-03-03OXAZEPAM
19ANDA072251_001RXOXAZEPAM (10MG)ORALCAPSULEFalseAB1988-04-14OXAZEPAM
20ANDA072252_001RXOXAZEPAM (15MG)ORALCAPSULEFalseAB1988-04-14OXAZEPAM
21ANDA072253_001RXOXAZEPAM (30MG)ORALCAPSULETrueAB1988-04-14OXAZEPAM
22ANDA072952_001discontinuedOXAZEPAM (10MG)ORALCAPSULEFalse1990-09-28OXAZEPAM
23ANDA072953_001discontinuedOXAZEPAM (15MG)ORALCAPSULEFalse1990-09-28OXAZEPAM
24ANDA072954_001discontinuedOXAZEPAM (30MG)ORALCAPSULEFalse1990-09-28OXAZEPAM
25NDA015539_002discontinuedOXAZEPAM (10MG)ORALCAPSULEFalseSERAX
26NDA015539_004discontinuedOXAZEPAM (15MG)ORALCAPSULEFalseSERAX
27NDA015539_006discontinuedOXAZEPAM (30MG)ORALCAPSULEFalseSERAX
28NDA015539_008discontinuedOXAZEPAM (15MG)ORALTABLETFalseSERAX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
103440821-831c-4085-98f9-faa88e98c503 (view SPL)OXAZEPAM CAPSULES, USP CIV Rx onlyprescriptionHuman PrescriptionAmerican Health Packagingrepack2015-10-214625840812, 625840813, 625840814
2140d8f61-912b-449a-9c34-b52e08b3d819 (view SPL)Oxazepam Capsules, USPprescriptionHuman PrescriptionSandoz Inc2011-10-2111007812809, 007812810, 007812811
33bccbfa9-fdcf-44c3-86f5-028ca92223ca (view SPL)OXAZEPAM CAPSULES, USPprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, Inc.Repack2014-03-312675440117, 675440268
452488349-1c84-4cdc-89d1-c841a68e904f (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-09-061493490715
58b11788c-2386-4c4a-a9b0-de2bdccbadaa (view SPL)OXAZEPAM CAPSULES, USP CIV 40-9021 Revised January 2008 Rx onlyprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2012-08-151433530074
6a0d5a4c1-ec79-42e6-8e8f-ae4d144edb43 (view SPL)OXAZEPAM CAPSULES, USPprescriptionHuman PrescriptionActavis Elizabeth LlcANALYSIS, MANUFACTURE2012-03-023002282067, 002282069, 002282073
7a70c61ac-412c-4886-9c5e-7b7e5d84fbb5 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llc2009-12-152165900304
8e2ccffa0-039d-b77d-5b10-c3e485ab2b99 (view SPL)OXAZEPAM CAPSULES, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-06-133636294298

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII