tizanidine Oral Capsule

Brand(s)
Zanaflex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Watson Laboratories, Inc. (2015-04-01)
Oldest Current Product
2002-08-29
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\TIZANIDINE
FDAOB
ORAL\CAPSULE\TIZANIDINE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE, GELATIN COATED\TIZANIDINE HYDROCHLORIDE
ORAL\CAPSULE\TIZANIDINE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\TIZANIDINE
ORAL\CAPSULE\TIZANIDINE

product(s) by strength(s)

tizanidine 2 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005912788NDAWatson Laboratories, Inc.2012-02-06TIZANIDINE HYDROCHLORIDEORALCAPSULE, GELATIN COATEDNDA021447cb8b01b3-bcec-4762-9d67-0db018ef6b22

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003781665ANDAMylan Pharmaceuticals Inc.2013-03-01TIZANIDINE HYDROCHLORIDEORALCAPSULEANDA0915021af9bfdd-48b9-4096-b673-3bb8c2d0512e
2605052648ANDAApotex Corp2012-02-06TIZANIDINE HYDROCHLORIDEORALCAPSULE, GELATIN COATEDANDA0788683dd09a0d-a782-1d6d-a552-b71e5bcbf2fe

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560341ZanaflexNDALake Erie Medical Dba Quality Care Products Llc2012-03-28TIZANIDINE HYDROCHLORIDEORALCAPSULE101440602NDA021447ce7e8b54-9ca1-4ebb-9df3-a291eb53674f
2422910810ANDAAvkare, Inc.2014-06-20TIZANIDINE HYDROCHLORIDEORALCAPSULE, GELATIN COATED605052648ANDA078868acc8f9f6-ceb6-0505-8f11-fd7e1f105af3
3581182788NDAClinical Solutions Wholesale2012-02-06TIZANIDINE HYDROCHLORIDEORALCAPSULE, GELATIN COATED005912788NDA021447607392db-547a-421f-9f96-079e5a55a2cd

tizanidine 4 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005912789NDAWatson Laboratories, Inc.2012-02-06TIZANIDINE HYDROCHLORIDEORALCAPSULE, GELATIN COATEDNDA021447cb8b01b3-bcec-4762-9d67-0db018ef6b22

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003781666ANDAMylan Pharmaceuticals Inc.2013-03-01TIZANIDINE HYDROCHLORIDEORALCAPSULEANDA0915021af9bfdd-48b9-4096-b673-3bb8c2d0512e
2605052649ANDAApotex Corp2012-02-06TIZANIDINE HYDROCHLORIDEORALCAPSULE, GELATIN COATEDANDA0788683dd09a0d-a782-1d6d-a552-b71e5bcbf2fe

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900871ZanaflexNDAStat Rx Usa Llc2002-08-29TIZANIDINE HYDROCHLORIDEORALCAPSULE101440604NDA021447939d9fec-727e-488e-adc4-cc941292b23e
2216950373ZanaflexNDARebel Distributors Corp2002-08-29TIZANIDINE HYDROCHLORIDEORALCAPSULE, GELATIN COATED101440604NDA021447b581d63f-61cb-41b6-a7ca-24bd0b32a8ae
3353560342ZanaflexNDALake Erie Medical Dba Quality Care Products Llc2012-03-28TIZANIDINE HYDROCHLORIDEORALCAPSULE101440604NDA021447ce7e8b54-9ca1-4ebb-9df3-a291eb53674f
4422910811ANDAAvkare, Inc.2014-06-20TIZANIDINE HYDROCHLORIDEORALCAPSULE, GELATIN COATED605052649ANDA078868acc8f9f6-ceb6-0505-8f11-fd7e1f105af3

tizanidine 6 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005912790NDAWatson Laboratories, Inc.2012-02-06TIZANIDINE HYDROCHLORIDEORALCAPSULE, GELATIN COATEDNDA021447cb8b01b3-bcec-4762-9d67-0db018ef6b22

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003781667ANDAMylan Pharmaceuticals Inc.2013-03-01TIZANIDINE HYDROCHLORIDEORALCAPSULEANDA0915021af9bfdd-48b9-4096-b673-3bb8c2d0512e
2605052650ANDAApotex Corp2012-02-06TIZANIDINE HYDROCHLORIDEORALCAPSULE, GELATIN COATEDANDA0788683dd09a0d-a782-1d6d-a552-b71e5bcbf2fe

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900756ZanaflexNDAStat Rx Usa Llc2002-08-29TIZANIDINE HYDROCHLORIDEORALCAPSULE101440606NDA021447939d9fec-727e-488e-adc4-cc941292b23e
2353560446ZanaflexNDALake Erie Medical Dba Quality Care Products Llc2012-03-28TIZANIDINE HYDROCHLORIDEORALCAPSULE101440606NDA021447ce7e8b54-9ca1-4ebb-9df3-a291eb53674f
3422910812ANDAAvkare, Inc.2014-06-20TIZANIDINE HYDROCHLORIDEORALCAPSULE, GELATIN COATED605052650ANDA078868acc8f9f6-ceb6-0505-8f11-fd7e1f105af3
4636295139NDABryant Ranch Prepack2012-02-06TIZANIDINE HYDROCHLORIDEORALCAPSULE, GELATIN COATED005912790NDA021447b703f118-c09d-41a3-b256-d2edd16350c8

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA078868TIZANIDINE HYDROCHLORIDEAPOTEX INC2012-02-03ANDA078868_001, ANDA078868_002, ANDA078868_003
2ANDA091502TIZANIDINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2012-11-09ANDA091502_001, ANDA091502_002, ANDA091502_003
3NDA021447ZANAFLEXACORDA THERAPEUTICS INC2002-08-29NDA021447_001, NDA021447_002, NDA021447_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078868_001RXTIZANIDINE HYDROCHLORIDE (EQ 2MG BASE)ORALCAPSULEFalseAB2012-02-03TIZANIDINE HYDROCHLORIDE
2ANDA078868_002RXTIZANIDINE HYDROCHLORIDE (EQ 4MG BASE)ORALCAPSULEFalseAB2012-02-03TIZANIDINE HYDROCHLORIDE
3ANDA078868_003RXTIZANIDINE HYDROCHLORIDE (EQ 6MG BASE)ORALCAPSULEFalseAB2012-02-03TIZANIDINE HYDROCHLORIDE
4ANDA091502_001RXTIZANIDINE HYDROCHLORIDE (EQ 2MG BASE)ORALCAPSULEFalseAB2012-11-09TIZANIDINE HYDROCHLORIDE
5ANDA091502_002RXTIZANIDINE HYDROCHLORIDE (EQ 4MG BASE)ORALCAPSULEFalseAB2012-11-09TIZANIDINE HYDROCHLORIDE
6ANDA091502_003RXTIZANIDINE HYDROCHLORIDE (EQ 6MG BASE)ORALCAPSULEFalseAB2012-11-09TIZANIDINE HYDROCHLORIDE
7NDA021447_001RXTIZANIDINE HYDROCHLORIDE (EQ 2MG BASE)ORALCAPSULEFalseAB2002-08-29ZANAFLEX
8NDA021447_002RXTIZANIDINE HYDROCHLORIDE (EQ 4MG BASE)ORALCAPSULEFalseAB2002-08-29ZANAFLEX
9NDA021447_003RXTIZANIDINE HYDROCHLORIDE (EQ 6MG BASE)ORALCAPSULETrueAB2002-08-29ZANAFLEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
11af9bfdd-48b9-4096-b673-3bb8c2d0512e (view SPL)These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules.TIZANIDINE hydrochloride capsules, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-04-184003781665, 003781666, 003781667
23dd09a0d-a782-1d6d-a552-b71e5bcbf2fe (view SPL)These highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE capsules, for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2014-01-143605052648, 605052649, 605052650
3413ee468-c7e8-4283-8e2b-b573dcc1f607 (view SPL)These highlights do not include all the information needed to use ZANAFLEX safely and effectively. See full prescribing information for ZANAFLEX. ZANAFLEX Capsules (tizanidine hydrochloride) capsules, for oral use ZANAFLEX (tizanidine hydrochloride) tablets, for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionAcorda Therapeutics, Inc.LABEL, MANUFACTURE, PACK2013-11-1111101440594, 101440602, 101440604, 101440606tizanidine Oral Tablet
4607392db-547a-421f-9f96-079e5a55a2cd (view SPL)Tizanidine Hydrochloride CapsulesprescriptionHuman PrescriptionClinical Solutions Wholesalerelabel, repack2013-07-081581182788
5939d9fec-727e-488e-adc4-cc941292b23e (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-04-251165900756, 165900871
6acc8f9f6-ceb6-0505-8f11-fd7e1f105af3 (view SPL)These highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE capsules, for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionAvkare, Inc.2014-06-231422910810, 422910811, 422910812
7b581d63f-61cb-41b6-a7ca-24bd0b32a8ae (view SPL)Zanaflex Capsules Zanaflex TabletsprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-011216950373
8b703f118-c09d-41a3-b256-d2edd16350c8 (view SPL)Tizanidine Hydrochloride CapsulesprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-231000636295139
9cb8b01b3-bcec-4762-9d67-0db018ef6b22 (view SPL)These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules . TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 2002prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-04-016005912788, 005912789, 005912790
10ce7e8b54-9ca1-4ebb-9df3-a291eb53674f (view SPL)Zanaflex Capsule Zanaflex TabletsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-03-283717353560341, 353560342, 353560446

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