Loxapine Oral Capsule

Brand(s)
Loxitane
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Lannett Company, Inc. (2011-08-16)
Oldest Current Product
1988-06-15
License(s)
ANDA
RxNORM
ORAL CAPSULE\LOXAPINE
FDAOB
ORAL\CAPSULE\LOXAPINE SUCCINATE
ORAL\TABLET\LOXAPINE SUCCINATE
SPL Active
ORAL\CAPSULE\LOXAPINE SUCCINATE
SPL Moiety
ORAL\CAPSULE\LOXAPINE

product(s) by strength(s)

loxapine 10 mg oral capsule

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003787010ANDAMylan Pharmaceuticals Inc.2004-11-03LOXAPINE SUCCINATEORALCAPSULEANDA0767621a03c19b-d44f-ae98-f404-022eb8392677
2005271395ANDALannett Company, Inc.2011-09-26LOXAPINE SUCCINATEORALCAPSULEANDA090695509bad3c-b563-4042-b270-d28bde19f224
3005910370ANDAWatson Laboratories, Inc.1988-06-15LOXAPINE SUCCINATEORALCAPSULEANDA072205a6107bb1-3e23-4c5d-bbf4-5e29deff6728
4428060526ANDAEpic Pharma, Llc2015-01-02LOXAPINE SUCCINATEORALCAPSULEANDA07686808c64801-6754-4483-be56-add862db9a9a
5510790901ANDAMylan Institutional Inc.2004-12-15LOXAPINE SUCCINATEORALCAPSULEANDA0767620c0a9ed3-20c8-48c2-bc18-8b0b4260e300
6525440495LoxitaneANDAActavis Pharma, Inc.1988-06-15LOXAPINE SUCCINATEORALCAPSULEANDA072205a61ac8b0-d2eb-4546-a57b-2c296fb12699

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490121ANDARemedyrepack Inc.2010-12-08LOXAPINE SUCCINATEORALCAPSULE005910370ANDA0722054b9f0bba-1bdf-4be0-846e-e25761946f71
2521250942ANDARemedyrepack Inc.2014-05-21LOXAPINE SUCCINATEORALCAPSULE005271395ANDA0906956166d6cf-7a2e-4345-802b-50242c0fa895
3581180370ANDAClinical Solutions Wholesale1988-06-15LOXAPINE SUCCINATEORALCAPSULE005910370ANDA07220542f33d10-2c5f-4c73-b964-ef3c09d627ae
4680840002ANDAAmerican Health Packaging2013-06-24LOXAPINE SUCCINATEORALCAPSULE005271395ANDA09069539d504f9-250a-458e-aa65-7439fa25aaeb

loxapine 25 mg oral capsule

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003787025ANDAMylan Pharmaceuticals Inc.2004-11-03LOXAPINE SUCCINATEORALCAPSULEANDA0767621a03c19b-d44f-ae98-f404-022eb8392677
2005271396ANDALannett Company, Inc.2011-09-26LOXAPINE SUCCINATEORALCAPSULEANDA090695509bad3c-b563-4042-b270-d28bde19f224
3005910371ANDAWatson Laboratories, Inc.1988-06-15LOXAPINE SUCCINATEORALCAPSULEANDA072206a6107bb1-3e23-4c5d-bbf4-5e29deff6728
4428060527ANDAEpic Pharma, Llc2015-01-02LOXAPINE SUCCINATEORALCAPSULEANDA07686808c64801-6754-4483-be56-add862db9a9a
5510790902ANDAMylan Institutional Inc.2004-12-15LOXAPINE SUCCINATEORALCAPSULEANDA0767620c0a9ed3-20c8-48c2-bc18-8b0b4260e300
6525440496LoxitaneANDAActavis Pharma, Inc.1988-06-15LOXAPINE SUCCINATEORALCAPSULEANDA072206a61ac8b0-d2eb-4546-a57b-2c296fb12699

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490481ANDARemedyrepack Inc.2011-08-15LOXAPINE SUCCINATEORALCAPSULE005910371ANDA07220629eb29a8-0a20-4e4a-beb8-edab431acdb4
2581180371ANDAClinical Solutions Wholesale1988-06-15LOXAPINE SUCCINATEORALCAPSULE005910371ANDA07220642f33d10-2c5f-4c73-b964-ef3c09d627ae
3680840003ANDAAmerican Health Packaging2013-06-24LOXAPINE SUCCINATEORALCAPSULE005271396ANDA09069539d504f9-250a-458e-aa65-7439fa25aaeb

loxapine 5 mg oral capsule

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003787005ANDAMylan Pharmaceuticals Inc.2004-11-03LOXAPINE SUCCINATEORALCAPSULEANDA0767621a03c19b-d44f-ae98-f404-022eb8392677
2005271394ANDALannett Company, Inc.2011-09-26LOXAPINE SUCCINATEORALCAPSULEANDA090695509bad3c-b563-4042-b270-d28bde19f224
3005910369ANDAWatson Laboratories, Inc.1988-06-15LOXAPINE SUCCINATEORALCAPSULEANDA072204a6107bb1-3e23-4c5d-bbf4-5e29deff6728
4428060525ANDAEpic Pharma, Llc2015-01-02LOXAPINE SUCCINATEORALCAPSULEANDA07686808c64801-6754-4483-be56-add862db9a9a
5525440494LoxitaneANDAActavis Pharma, Inc.1988-06-15LOXAPINE SUCCINATEORALCAPSULEANDA072204a61ac8b0-d2eb-4546-a57b-2c296fb12699

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490102ANDARemedyrepack Inc.2010-11-30LOXAPINE SUCCINATEORALCAPSULE005910369ANDA0722047cf28cc7-ca73-4565-b05a-55629c457804
2493490513ANDARemedyrepack Inc.2011-09-15LOXAPINE SUCCINATEORALCAPSULE005910369ANDA0722041b0bcd3d-de49-4a1a-b94c-8a3853175580
3581180369ANDAClinical Solutions Wholesale1988-06-15LOXAPINE SUCCINATEORALCAPSULE005910369ANDA07220442f33d10-2c5f-4c73-b964-ef3c09d627ae
4681512875ANDACarilion Materials Management1988-06-15LOXAPINE SUCCINATEORALCAPSULE005910369ANDA072204337bb945-64b9-4da5-8c10-1aead291c184

loxapine 50 mg oral capsule

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003787050ANDAMylan Pharmaceuticals Inc.2004-11-03LOXAPINE SUCCINATEORALCAPSULEANDA0767621a03c19b-d44f-ae98-f404-022eb8392677
2005271397ANDALannett Company, Inc.2011-09-26LOXAPINE SUCCINATEORALCAPSULEANDA090695509bad3c-b563-4042-b270-d28bde19f224
3005910372ANDAWatson Laboratories, Inc.1988-06-15LOXAPINE SUCCINATEORALCAPSULEANDA072062a6107bb1-3e23-4c5d-bbf4-5e29deff6728
4428060528ANDAEpic Pharma, Llc2015-01-02LOXAPINE SUCCINATEORALCAPSULEANDA07686808c64801-6754-4483-be56-add862db9a9a
5510790903ANDAMylan Institutional Inc.2004-12-15LOXAPINE SUCCINATEORALCAPSULEANDA0767620c0a9ed3-20c8-48c2-bc18-8b0b4260e300
6525440497LoxitaneANDAActavis Pharma, Inc.1988-06-15LOXAPINE SUCCINATEORALCAPSULEANDA072062a61ac8b0-d2eb-4546-a57b-2c296fb12699

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490212ANDARemedyrepack Inc.2011-04-26LOXAPINE SUCCINATEORALCAPSULE005910372ANDA0720620cbedaf8-da10-4a1c-8ca7-abf93723ca92
2493490514ANDARemedyrepack Inc.2011-09-15LOXAPINE SUCCINATEORALCAPSULE005910372ANDA072062e8920d77-5d6e-4dc3-ad80-8b54861d93f8
3581180372ANDAClinical Solutions Wholesale1988-06-15LOXAPINE SUCCINATEORALCAPSULE005910372ANDA07206242f33d10-2c5f-4c73-b964-ef3c09d627ae
4680840004ANDAAmerican Health Packaging2013-06-24LOXAPINE SUCCINATEORALCAPSULE005271397ANDA09069539d504f9-250a-458e-aa65-7439fa25aaeb

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA072062LOXAPINE SUCCINATEWATSON LABORATORIES INC1988-06-15ANDA072062_001
2ANDA072204LOXAPINE SUCCINATEWATSON LABORATORIES INC1988-06-15ANDA072204_001
3ANDA072205LOXAPINE SUCCINATEWATSON LABORATORIES INC1988-06-15ANDA072205_001
4ANDA072206LOXAPINE SUCCINATEWATSON LABORATORIES INC1988-06-15ANDA072206_001
5ANDA076762LOXAPINE SUCCINATEMYLAN PHARMACEUTICALS INC2004-11-01ANDA076762_001, ANDA076762_002, ANDA076762_003, ANDA076762_004
6ANDA076868LOXAPINE SUCCINATEELITE LABORATORIES INC2005-08-04ANDA076868_001, ANDA076868_002, ANDA076868_003, ANDA076868_004
7ANDA090695LOXAPINE SUCCINATELANNETT HOLDINGS INC2011-09-26ANDA090695_001, ANDA090695_002, ANDA090695_003, ANDA090695_004
8NDA017525LOXITANETrueACTAVIS LABORATORIES UT INCNDA017525_001, NDA017525_002, NDA017525_003, NDA017525_004, NDA017525_006, NDA017525_007, NDA017525_008

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA072062_001RXLOXAPINE SUCCINATE (EQ 50MG BASE)ORALCAPSULEFalseAB1988-06-15LOXAPINE SUCCINATE
2ANDA072204_001RXLOXAPINE SUCCINATE (EQ 5MG BASE)ORALCAPSULEFalseAB1988-06-15LOXAPINE SUCCINATE
3ANDA072205_001RXLOXAPINE SUCCINATE (EQ 10MG BASE)ORALCAPSULEFalseAB1988-06-15LOXAPINE SUCCINATE
4ANDA072206_001RXLOXAPINE SUCCINATE (EQ 25MG BASE)ORALCAPSULETrueAB1988-06-15LOXAPINE SUCCINATE
5ANDA076762_001RXLOXAPINE SUCCINATE (EQ 5MG BASE)ORALCAPSULEFalseAB2004-11-01LOXAPINE SUCCINATE
6ANDA076762_002RXLOXAPINE SUCCINATE (EQ 10MG BASE)ORALCAPSULEFalseAB2004-11-01LOXAPINE SUCCINATE
7ANDA076762_003RXLOXAPINE SUCCINATE (EQ 25MG BASE)ORALCAPSULEFalseAB2004-11-01LOXAPINE SUCCINATE
8ANDA076762_004RXLOXAPINE SUCCINATE (EQ 50MG BASE)ORALCAPSULEFalseAB2004-11-01LOXAPINE SUCCINATE
9ANDA076868_001RXLOXAPINE SUCCINATE (EQ 5MG BASE)ORALCAPSULEFalseAB2005-08-04LOXAPINE SUCCINATE
10ANDA076868_002RXLOXAPINE SUCCINATE (EQ 10MG BASE)ORALCAPSULEFalseAB2005-08-04LOXAPINE SUCCINATE
11ANDA076868_003RXLOXAPINE SUCCINATE (EQ 25MG BASE)ORALCAPSULEFalseAB2005-08-04LOXAPINE SUCCINATE
12ANDA076868_004RXLOXAPINE SUCCINATE (EQ 50MG BASE)ORALCAPSULEFalseAB2005-08-04LOXAPINE SUCCINATE
13ANDA090695_001RXLOXAPINE SUCCINATE (EQ 5MG BASE)ORALCAPSULEFalseAB2011-09-26LOXAPINE SUCCINATE
14ANDA090695_002RXLOXAPINE SUCCINATE (EQ 10MG BASE)ORALCAPSULEFalseAB2011-09-26LOXAPINE SUCCINATE
15ANDA090695_003RXLOXAPINE SUCCINATE (EQ 25MG BASE)ORALCAPSULEFalseAB2011-09-26LOXAPINE SUCCINATE
16ANDA090695_004RXLOXAPINE SUCCINATE (EQ 50MG BASE)ORALCAPSULEFalseAB2011-09-26LOXAPINE SUCCINATE
17NDA017525_001discontinuedLOXAPINE SUCCINATE (EQ 5MG BASE)ORALCAPSULEFalseLOXITANE
18NDA017525_002discontinuedLOXAPINE SUCCINATE (EQ 10MG BASE)ORALCAPSULEFalseLOXITANE
19NDA017525_003discontinuedLOXAPINE SUCCINATE (EQ 25MG BASE)ORALCAPSULEFalseLOXITANE
20NDA017525_004discontinuedLOXAPINE SUCCINATE (EQ 50MG BASE)ORALCAPSULEFalseLOXITANE
21NDA017525_006discontinuedLOXAPINE SUCCINATE (EQ 10MG BASE)ORALTABLETFalseLOXITANE
22NDA017525_007discontinuedLOXAPINE SUCCINATE (EQ 25MG BASE)ORALTABLETFalseLOXITANE
23NDA017525_008discontinuedLOXAPINE SUCCINATE (EQ 50MG BASE)ORALTABLETFalseLOXITANE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
108c64801-6754-4483-be56-add862db9a9a (view SPL)Loxapine Capsules USP, 5 mg, 10 mg, 25 mg and 50 mgRx OnlyprescriptionHuman PrescriptionEpic Pharma, LlcMANUFACTURE2015-05-113428060525, 428060526, 428060527, 428060528
20c0a9ed3-20c8-48c2-bc18-8b0b4260e300 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2012-12-073510790901, 510790902, 510790903
30cbedaf8-da10-4a1c-8ca7-abf93723ca92 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-04-261493490212
41a03c19b-d44f-ae98-f404-022eb8392677 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2010-09-155003787005, 003787010, 003787025, 003787050
51b0bcd3d-de49-4a1a-b94c-8a3853175580 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-09-152493490513
629eb29a8-0a20-4e4a-beb8-edab431acdb4 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-08-151493490481
7337bb945-64b9-4da5-8c10-1aead291c184 (view SPL)Loxapine Capsules USP Revised: September 2010 Rx only 174374-2prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2011-02-042681512875
839d504f9-250a-458e-aa65-7439fa25aaeb (view SPL)Loxapine Capsules, USPprescriptionHuman PrescriptionAmerican Health Packagingrepack2015-10-202680840002, 680840003, 680840004
942f33d10-2c5f-4c73-b964-ef3c09d627ae (view SPL)Loxapine Capsules USP Revised: September 2010 Rx only 174374-2prescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2014-07-011581180369, 581180370, 581180371, 581180372
104b9f0bba-1bdf-4be0-846e-e25761946f71 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2010-12-08129493490121
11509bad3c-b563-4042-b270-d28bde19f224 (view SPL)Loxapine Capsules, USPprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-08-166005271394, 005271395, 005271396, 005271397
126166d6cf-7a2e-4345-802b-50242c0fa895 (view SPL)Loxapine Capsules, USPprescriptionHuman PrescriptionRemedyrepack Inc.2014-05-211521250942
137cf28cc7-ca73-4565-b05a-55629c457804 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2010-11-30114493490102
14a6107bb1-3e23-4c5d-bbf4-5e29deff6728 (view SPL)LoxapineCapsules USPRevised: September 2010Rx only174374-2prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-02-0413005910369, 005910370, 005910371, 005910372
15a61ac8b0-d2eb-4546-a57b-2c296fb12699 (view SPL)LoxitaneprescriptionHuman PrescriptionActavis Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-02-036525440494, 525440495, 525440496, 525440497
16e8920d77-5d6e-4dc3-ad80-8b54861d93f8 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-09-156493490514

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