tizanidine Oral Tablet

Brand(s)
Zanaflex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Acorda Therapeutics, Inc. (2013-11-11)
Oldest Current Product
1997-01-01
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\TIZANIDINE
FDAOB
ORAL\TABLET\TIZANIDINE HYDROCHLORIDE
SPL Active
ORAL\TABLET\TIZANIDINE
ORAL\TABLET\TIZANIDINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\TIZANIDINE

product(s) by strength(s)

tizanidine 2 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850034ANDAEon Labs, Inc.2002-11-26TIZANIDINE HYDROCHLORIDEORALTABLETANDA0762801fa26940-3778-4758-811e-3e1531d919df
2003780722ANDAMylan Pharmaceuticals Inc.2003-05-06TIZANIDINE HYDROCHLORIDEORALTABLETANDA076354b4227d39-6f9e-5ded-4169-087ce91a75b5
3293000168ANDAUnichem Pharmaceuticals (Usa), Inc.2013-04-01TIZANIDINE HYDROCHLORIDEORALTABLETANDA091283a3fa9c69-4baf-44f5-bac4-a19c34b0e1cb
4551110179ANDADr. Reddy'S Laboratories Ltd2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLETANDA076286a42f3479-f2c2-8214-d547-c5cae9bfed1e
5576640502ANDACaraco Pharmaceutical Laboratories, Ltd.2003-12-11TIZANIDINE HYDROCHLORIDEORALTABLETANDA0764164659df31-8b89-4eff-9d86-7b7e38de416b
6605050251ANDAApotex Corp2004-01-16TIZANIDINE HYDROCHLORIDEORALTABLETANDA07653301c0d3d3-2373-a1b7-822a-80a66291a248
7647200106ANDACorepharma, Llc2007-02-06TIZANIDINE HYDROCHLORIDEORALTABLETANDA076347e0132fe9-b145-4324-9f41-a86fe6ac2b85

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006156564ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110179ANDA076286234b4e5e-8305-4d2d-840e-e69f0219c6fb
2105440587ANDABlenheim Pharmacal, Inc.2014-01-13TIZANIDINE HYDROCHLORIDEORALTABLET605050251ANDA07653310457e1d-068f-7071-e054-00144ff8d46c
3105440863ANDABlenheim Pharmacal, Inc.2014-04-08TIZANIDINE HYDROCHLORIDEORALTABLET605050251ANDA0765331fe204a5-8ca8-1fa1-e054-00144ff8d46c
4165900220ANDAStat Rx Usa Llc2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110179ANDA076286a204c899-a892-41db-a96b-45478e5588f2
5216950126ANDARebel Distributors Corp2007-02-06TIZANIDINE HYDROCHLORIDEORALTABLET647200106ANDA0763474f0d83de-0810-4255-8114-443f8fb915de
6332610103ANDAAidarex Pharmaceuticals Llc2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110179ANDA0762869852284f-0101-4167-81d5-e74732b95e8f
7353560662ANDALake Erie Medical Dba Quality Care Products Llc2007-02-06TIZANIDINE HYDROCHLORIDEORALTABLET647200106ANDA076347b68a9f81-7138-48cf-b987-b8d284e8105a
8422910808ANDAAvkare, Inc.2015-07-23TIZANIDINE HYDROCHLORIDEORALTABLET576640502ANDA076416150c131c-3dc5-8417-2dc0-d0d440fb1d34
9425490549ANDAStat Rx Usa Llc2002-11-26TIZANIDINE HYDROCHLORIDEORALTABLET001850034ANDA07628043d51c1d-5f5b-4b9e-95d0-d12ceff8d84e
10433530946ANDAAphena Pharma Solutions - Tennessee, Llc2003-05-06TIZANIDINE HYDROCHLORIDEORALTABLET003780722ANDA076354a9ce2cc9-8a97-4965-bccc-32137eb2911a
11458650386ANDAMedsource Pharmaceuticals2009-01-05TIZANIDINE HYDROCHLORIDEORALTABLET551110179ANDA0762865a42267f-a400-4bfd-ad7c-fad335884ba8
12499990584ANDALake Erie Medical Dba Quality Care Products Llc2011-04-20TIZANIDINE HYDROCHLORIDEORALTABLET001850034ANDA076280fc1d0404-e9a8-4682-af4c-b9164d6e36ef
13504366755ANDAUnit Dose Services2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110179ANDA076286988cbeae-64ed-4ce1-b503-f5e7b77f1a2a
14521250408ANDARemedyrepack Inc.2013-05-15TIZANIDINE HYDROCHLORIDEORALTABLET551110179ANDA076286945b3469-b0a6-419e-b95b-d1d3013ccc0c
15521250553ANDARemedyrepack Inc.2013-05-23TIZANIDINE HYDROCHLORIDEORALTABLET551110179ANDA076286ba7420e1-7db3-44b3-be95-369e5cb7cc33
16529590691ANDAH.J. Harkins Company, Inc.2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110179ANDA0762866d8e0262-5ccf-4447-90dd-f5eec069664c
17548684964ANDAPhysicians Total Care, Inc.2004-03-03TIZANIDINE HYDROCHLORIDEORALTABLET551110179ANDA0762869d222859-6697-47bf-98ec-91984002e0d9
18551546256ANDACardinal Health2013-03-21TIZANIDINE HYDROCHLORIDEORALTABLET003780722ANDA07635449f50d5e-3738-4f3a-8999-28c6a5ff2cd7
19552890809ANDAPd-Rx Pharmaceuticals, Inc.2002-11-26TIZANIDINE HYDROCHLORIDEORALTABLET001850034ANDA0762804c4de495-8f9c-4b74-8773-fdf6ad7290fc
20581180179ANDAClinical Solutions Wholesale2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110179ANDA076286449b1b6a-fdf5-4e29-b0a3-a962dbcdf843
21604290241ANDAGolden State Medical Supply, Inc.2004-01-16TIZANIDINE HYDROCHLORIDEORALTABLET605050251ANDA076533953db236-b848-484f-83b7-436c3a274c88
22607600782ANDASt Marys Medical Park Pharmacy2015-08-18TIZANIDINE HYDROCHLORIDEORALTABLET293000168ANDA091283d2f5bdfe-0bb2-4c54-953e-a44efe761ae0
23617860399ANDARemedyrepack Inc.2015-09-03TIZANIDINE HYDROCHLORIDEORALTABLET605050251ANDA07653310661b1d-d726-43f6-9546-597c70590748
24619190220ANDADirect Rx2014-01-01TIZANIDINE HYDROCHLORIDEORALTABLET605050251ANDA07653354bd58ee-76f6-44e7-83bb-fe752c3cbf9a
25636293209ANDABryant Ranch Prepack2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110179ANDA07628682084f4e-00d0-c298-c13a-88a6c0860b02
26638740087ANDAAltura Pharmaceuticals, Inc.2010-01-01TIZANIDINE HYDROCHLORIDEORALTABLET551110179ANDA0762869c70817f-e721-4f04-b095-0747702df614
27680840775ANDAAmerican Health Packaging2014-06-02TIZANIDINE HYDROCHLORIDEORALTABLET551110179ANDA0762863670f9e3-988d-48e6-9df0-d403d699e08a
28683870130ANDAKeltman Pharmaceuticals Inc.2005-06-01TIZANIDINE HYDROCHLORIDEORALTABLET647200106ANDA0763470df212f5-f77b-4d94-8fd0-0b40d0e9a1c8
29687889091ANDAPreferred Pharmaceuticals, Inc.2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110179ANDA076286fce6f784-cfc5-49ef-af1f-fa6dc389ed3e
30687889497ANDAPreferred Pharmaceuticals, Inc.2014-03-26TIZANIDINE HYDROCHLORIDEORALTABLET605050251ANDA076533e4723fbe-ad87-4d72-9c20-b0621f349dfc

tizanidine 4 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1101440594ZanaflexNDAAcorda Therapeutics, Inc.1997-01-01TIZANIDINE HYDROCHLORIDEORALTABLETNDA020397413ee468-c7e8-4283-8e2b-b573dcc1f607

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001854400ANDAEon Labs, Inc.2002-06-27TIZANIDINE HYDROCHLORIDEORALTABLETANDA0762801fa26940-3778-4758-811e-3e1531d919df
2003780724ANDAMylan Pharmaceuticals Inc.2003-05-06TIZANIDINE HYDROCHLORIDEORALTABLETANDA076354b4227d39-6f9e-5ded-4169-087ce91a75b5
3009046193ANDAMajor2010-07-16TIZANIDINE HYDROCHLORIDEORALTABLETANDA0762808c442290-31c1-40ea-aacc-935e85c221d0
4009046418ANDAMajor2014-10-01TIZANIDINE HYDROCHLORIDEORALTABLETANDA076533d24e0cda-a22f-404f-b861-f85090cef099
5430630237ANDAPd-Rx Pharmaceuticals, Inc.2013-07-09ANDA07628021a88e86-c692-47d6-8ade-8641ea19df98
6551110180ANDADr. Reddy'S Laboratories Ltd2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLETANDA076286a42f3479-f2c2-8214-d547-c5cae9bfed1e
7576640503ANDACaraco Pharmaceutical Laboratories, Ltd.2003-12-11TIZANIDINE HYDROCHLORIDEORALTABLETANDA0764164659df31-8b89-4eff-9d86-7b7e38de416b
8585170380ANDANew Horizon Rx Group, Llc2013-08-25TIZANIDINEORALTABLETANDA076416d0182933-afae-4db4-9aa1-a869dcf39658
9605050252ANDAApotex Corp2004-01-16TIZANIDINE HYDROCHLORIDEORALTABLETANDA07653301c0d3d3-2373-a1b7-822a-80a66291a248
10647200138ANDACorepharma, Llc2007-02-06TIZANIDINE HYDROCHLORIDEORALTABLETANDA076347e0132fe9-b145-4324-9f41-a86fe6ac2b85

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006155574ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA076286234b4e5e-8305-4d2d-840e-e69f0219c6fb
2105440576ANDABlenheim Pharmacal, Inc.2014-01-22TIZANIDINE HYDROCHLORIDEORALTABLET605050252ANDA0765334e2fd72f-4e76-411c-9ab8-441547141b34
3105440890ANDABlenheim Pharmacal, Inc.2014-12-18TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA0762860ed87a81-6ba1-2d8a-e054-00144ff8d46c
4165900221ANDAStat Rx Usa Llc2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA076286a204c899-a892-41db-a96b-45478e5588f2
5216950127ANDARebel Distributors Corp2007-02-06TIZANIDINE HYDROCHLORIDEORALTABLET647200138ANDA0763474f0d83de-0810-4255-8114-443f8fb915de
6332610104ANDAAidarex Pharmaceuticals Llc2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA0762869852284f-0101-4167-81d5-e74732b95e8f
7422910809ANDAAvkare, Inc.2015-07-23TIZANIDINE HYDROCHLORIDEORALTABLET576640503ANDA076416150c131c-3dc5-8417-2dc0-d0d440fb1d34
8425490597ANDAStat Rx Usa Llc2002-06-27TIZANIDINE HYDROCHLORIDEORALTABLET001854400ANDA07628043d51c1d-5f5b-4b9e-95d0-d12ceff8d84e
9430630455ANDAPd-Rx Pharmaceuticals, Inc.2012-07-24TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA076286ac897a5a-677b-4a6e-abb1-b810470200fc
10433530914ANDAAphena Pharma Solutions - Tennessee, Llc2003-05-06TIZANIDINE HYDROCHLORIDEORALTABLET003780724ANDA076354a9ce2cc9-8a97-4965-bccc-32137eb2911a
11458650348ANDAMedsource Pharmaceuticals2008-12-08TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA076286c14fa366-721d-47d1-928a-ae2fb250752d
12493490579ANDARemedyrepack Inc.2014-11-21TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA07628673592fc0-4f9d-4812-81ab-3a8abc89145a
13499990347ANDALake Erie Medical Dba Quality Care Products Llc2010-11-23TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA07628687f8a776-e8ae-4aed-a221-98ca72a2bedf
14504366756ANDAUnit Dose Services2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA076286204984ed-771c-4249-bba5-50d51c60e901
15510790998ANDAMylan Institutional Inc.2003-06-15TIZANIDINE HYDROCHLORIDEORALTABLET003780724ANDA07635479a0e9fc-589e-46ef-b9da-7aa3665bf1e2
16521250390ANDARemedyrepack Inc.2013-02-19, 2014-07-14TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA0762868f427e41-53cc-437e-9169-9242c86d50a5, b8650455-26cb-494a-82aa-c8388fdb67ff
17529590689ANDAH.J. Harkins Company, Inc.2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA0762866d8e0262-5ccf-4447-90dd-f5eec069664c
18548684939ANDAPhysicians Total Care, Inc.2004-01-19TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA0762869d222859-6697-47bf-98ec-91984002e0d9
19551543487ANDACardinal Health2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA0762866b6a34e2-4de2-4dd0-adca-40f32f8d854c
20551545068ANDACardinal Health2011-01-28TIZANIDINE HYDROCHLORIDEORALTABLET510790998ANDA07635468d22330-830a-41ea-8c51-c31441c5a451
21552890612ZanaflexNDAPd-Rx Pharmaceuticals, Inc.1997-01-01TIZANIDINE HYDROCHLORIDEORALTABLET101440594NDA020397338c33be-9578-40e8-bdff-64b4e1b74a2c
22552890784ANDAPd-Rx Pharmaceuticals, Inc.2002-06-27TIZANIDINE HYDROCHLORIDEORALTABLET001854400ANDA076280b2e8ab61-db55-4bf2-a7c9-1b74e95e5901
23581180180ANDAClinical Solutions Wholesale2002-06-27TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA076280a1a04baf-cfe0-40e8-817a-a0e17df45123
24604290242ANDAGolden State Medical Supply, Inc.2004-01-16TIZANIDINE HYDROCHLORIDEORALTABLET605050252ANDA076533953db236-b848-484f-83b7-436c3a274c88
25619190196ANDADirect Rx2014-01-01TIZANIDINE HYDROCHLORIDEORALTABLET293000169ANDA091283047c67cd-7a63-49c9-b100-71651d3537ba
26619190221ANDADirect Rx2014-01-01TIZANIDINE HYDROCHLORIDEORALTABLET605050252ANDA07653354bd58ee-76f6-44e7-83bb-fe752c3cbf9a
27631870009ANDAProficient Rx Lp2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA076286c2353d09-3cb4-486e-8ae7-29339c1ba76b
28631870145ANDAProficient Rx Lp2004-01-16TIZANIDINE HYDROCHLORIDEORALTABLET605050252ANDA076533cf77e63c-a62a-43fc-8705-0558925e04e8
29631870493ANDAProficient Rx Lp2013-04-01TIZANIDINE HYDROCHLORIDEORALTABLET293000169ANDA091283e13b111a-25b7-4fdd-a102-30f2996722f3
30636291673ANDABryant Ranch Prepack2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA076286b254a0f4-efb1-4874-ae45-1dc5fe316964
31663360843ANDADispensing Solutions, Inc.2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA0762860d2aaf19-74ae-4aff-a33a-1d1a54aa1b8c
32680840013ANDAAmerican Health Packaging2013-07-08TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA0762864779b047-0dd6-460d-9ec8-5be17ac5d2fa
33680840645ANDAAmerican Health Packaging2013-09-25TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA0762863670f9e3-988d-48e6-9df0-d403d699e08a
34683870140ANDAKeltman Pharmaceuticals Inc.2005-06-01TIZANIDINE HYDROCHLORIDEORALTABLET647200138ANDA0763470df212f5-f77b-4d94-8fd0-0b40d0e9a1c8
35687889092ANDAPreferred Pharmaceuticals, Inc.2002-07-03TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA076286fce6f784-cfc5-49ef-af1f-fa6dc389ed3e
36687889514ANDAPreferred Pharmaceuticals, Inc.2014-03-05TIZANIDINE HYDROCHLORIDEORALTABLET605050252ANDA076533e4723fbe-ad87-4d72-9c20-b0621f349dfc
37762370252ANDAMckesson Contract Packaging2012-02-23TIZANIDINE HYDROCHLORIDEORALTABLET551110180ANDA076286d0d913a9-cfe8-4a7e-b20d-ea51828a01a1

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076280TIZANIDINE HYDROCHLORIDESANDOZ INC2002-06-27ANDA076280_001, ANDA076280_002
2ANDA076281TIZANIDINE HYDROCHLORIDEPROSAM LABS LLC2003-10-20ANDA076281_001, ANDA076281_002
3ANDA076282TIZANIDINE HYDROCHLORIDETrueMYLAN PHARMACEUTICALS INC2003-12-16ANDA076282_001, ANDA076282_002
4ANDA076283TIZANIDINE HYDROCHLORIDETrueACTAVIS ELIZABETH LLC2002-07-12ANDA076283_001, ANDA076283_002
5ANDA076284TIZANIDINE HYDROCHLORIDETEVA PHARMACEUTICALS USA INC2002-07-03ANDA076284_001, ANDA076284_002
6ANDA076286TIZANIDINE HYDROCHLORIDEDR REDDYS LABORATORIES INC2002-07-03ANDA076286_001, ANDA076286_002
7ANDA076321TIZANIDINE HYDROCHLORIDETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2004-09-30ANDA076321_001, ANDA076321_002
8ANDA076347TIZANIDINE HYDROCHLORIDECOREPHARMA LLC2002-10-11ANDA076347_001, ANDA076347_002
9ANDA076354TIZANIDINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2003-03-28ANDA076354_001, ANDA076354_002
10ANDA076371TIZANIDINE HYDROCHLORIDETrueBARR LABORATORIES INC2003-04-09ANDA076371_001, ANDA076371_002
11ANDA076416TIZANIDINE HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES INC2003-09-29ANDA076416_001, ANDA076416_002
12ANDA076533TIZANIDINE HYDROCHLORIDEAPOTEX INC2004-01-16ANDA076533_001, ANDA076533_002
13ANDA091283TIZANIDINE HYDROCHLORIDEUNICHEM LABORATORIES LTD2012-11-28ANDA091283_001, ANDA091283_002
14NDA020397ZANAFLEXACORDA THERAPEUTICS INC1996-11-27NDA020397_001, NDA020397_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076280_001RXTIZANIDINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2002-11-26TIZANIDINE HYDROCHLORIDE
2ANDA076280_002RXTIZANIDINE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2002-06-27TIZANIDINE HYDROCHLORIDE
3ANDA076281_001RXTIZANIDINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2003-10-20TIZANIDINE HYDROCHLORIDE
4ANDA076281_002RXTIZANIDINE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2003-10-20TIZANIDINE HYDROCHLORIDE
5ANDA076282_001discontinuedTIZANIDINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalse2003-12-16TIZANIDINE HYDROCHLORIDE
6ANDA076282_002discontinuedTIZANIDINE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalse2003-12-16TIZANIDINE HYDROCHLORIDE
7ANDA076283_001discontinuedTIZANIDINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalse2002-07-12TIZANIDINE HYDROCHLORIDE
8ANDA076283_002discontinuedTIZANIDINE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalse2002-07-12TIZANIDINE HYDROCHLORIDE
9ANDA076284_001RXTIZANIDINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2002-07-03TIZANIDINE HYDROCHLORIDE
10ANDA076284_002RXTIZANIDINE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2002-07-03TIZANIDINE HYDROCHLORIDE
11ANDA076286_001RXTIZANIDINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2002-07-03TIZANIDINE HYDROCHLORIDE
12ANDA076286_002RXTIZANIDINE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2002-07-03TIZANIDINE HYDROCHLORIDE
13ANDA076321_001discontinuedTIZANIDINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalse2004-09-30TIZANIDINE HYDROCHLORIDE
14ANDA076321_002discontinuedTIZANIDINE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalse2004-09-30TIZANIDINE HYDROCHLORIDE
15ANDA076347_001RXTIZANIDINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2002-10-11TIZANIDINE HYDROCHLORIDE
16ANDA076347_002RXTIZANIDINE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2002-10-11TIZANIDINE HYDROCHLORIDE
17ANDA076354_001RXTIZANIDINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2003-03-28TIZANIDINE HYDROCHLORIDE
18ANDA076354_002RXTIZANIDINE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2003-03-28TIZANIDINE HYDROCHLORIDE
19ANDA076371_001discontinuedTIZANIDINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalse2003-04-09TIZANIDINE HYDROCHLORIDE
20ANDA076371_002discontinuedTIZANIDINE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalse2003-04-09TIZANIDINE HYDROCHLORIDE
21ANDA076416_001RXTIZANIDINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2003-09-29TIZANIDINE HYDROCHLORIDE
22ANDA076416_002RXTIZANIDINE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2003-09-29TIZANIDINE HYDROCHLORIDE
23ANDA076533_001RXTIZANIDINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2004-01-16TIZANIDINE HYDROCHLORIDE
24ANDA076533_002RXTIZANIDINE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2004-01-16TIZANIDINE HYDROCHLORIDE
25ANDA091283_001RXTIZANIDINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2012-11-28TIZANIDINE HYDROCHLORIDE
26ANDA091283_002RXTIZANIDINE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2012-11-28TIZANIDINE HYDROCHLORIDE
27NDA020397_001RXTIZANIDINE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETTrueAB1996-11-27ZANAFLEX
28NDA020397_002discontinuedTIZANIDINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalse2000-02-04ZANAFLEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
101c0d3d3-2373-a1b7-822a-80a66291a248 (view SPL)These highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2014-01-065605050251, 605050252
2047c67cd-7a63-49c9-b100-71651d3537ba (view SPL)TIZANIDINE HYDROCHLORIDEprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-02-121619190196
30d2aaf19-74ae-4aff-a33a-1d1a54aa1b8c (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-07-081663360843
40df212f5-f77b-4d94-8fd0-0b40d0e9a1c8 (view SPL)Tizanidine hydrochloride TabletsprescriptionHuman PrescriptionKeltman Pharmaceuticals Inc.repack2010-07-073683870130, 683870140
50ed87a81-6ba1-2d8a-e054-00144ff8d46c (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.2015-02-113105440890
610457e1d-068f-7071-e054-00144ff8d46c (view SPL)These highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-04-234105440587
710661b1d-d726-43f6-9546-597c70590748 (view SPL)These highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionRemedyrepack Inc.2015-09-031617860399
8150c131c-3dc5-8417-2dc0-d0d440fb1d34 (view SPL)Tizanidine Tablets, LabelThese highlights do not include all the information needed to useSee full prescribing information forInitial U.S. Approval: 1996prescriptionHuman PrescriptionAvkare, Inc.2015-08-262422910808, 422910809
91fa26940-3778-4758-811e-3e1531d919df (view SPL)These highlights do not include all the information needed to use Tizanidine Tablets USP safely and effectively. See full prescribing information for Tizanidine Tablets USP.Tizanidine Tablets USP, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionEon Labs, Inc.2014-10-0821001850034, 001854400
101fe204a5-8ca8-1fa1-e054-00144ff8d46c (view SPL)These highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-09-161105440863
11204984ed-771c-4249-bba5-50d51c60e901 (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionUnit Dose ServicesREPACK2009-09-303504366756
1221a88e86-c692-47d6-8ade-8641ea19df98 (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.manufacture, repack2012-05-081430630237
13234b4e5e-8305-4d2d-840e-e69f0219c6fb (view SPL)These highlights do not include all the information needed to usetizanidine hydrochloridesafely and effectively. See full prescribing information for tizanidine hydrochloride. TizanidineTablets, USP for oraluse Initial U.S. Approval: 1996 PHARMACOKINETIC DIFFERENCES BETWEEN TIZANIDINE CAPSULES AND TIZANIDINE TABLETS: TIZANIDINE CAPSULES ARE NOT BIOEQUIVALENT TO TIZANIDINE TABLETS IN THE FED STATE. THE PRESCRIBER SHOULD BE THOROUGHLY FAMILIAR WITH THE COMPLEX EFFECTS OF FOOD ON TIZANIDINE PHARMACOKINETICS (see PHARMACOKINETICS and DOSAGE AND ADMINISTRATION).prescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsREPACK2014-12-1611006155574, 006156564
14338c33be-9578-40e8-bdff-64b4e1b74a2c (view SPL)Zanaflex Capsule Zanaflex TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-01-097552890612
153670f9e3-988d-48e6-9df0-d403d699e08a (view SPL)These highlights do not include all the information needed to use tizanidine hydrochloride safely and effectively. See full prescribing information for tizanidine hydrochloride. TIZANIDINE tablets USP, for oral use Initial U.S. Approval: 1996 PHARMACOKINETIC DIFFERENCES BETWEEN TIZANIDINE CAPSULES AND TIZANIDINE TABLETS: TIZANIDINE CAPSULES ARE NOT BIOEQUIVALENT TO TIZANIDINE TABLETS IN THE FED STATE. THE PRESCRIBER SHOULD BE THOROUGHLY FAMILIAR WITH THE COMPLEX EFFECTS OF FOOD ON TIZANIDINE PHARMACOKINETICS (see PHARMACOKINETICS and DOSAGE AND ADMINISTRATION).prescriptionHuman PrescriptionAmerican Health Packagingrepack2015-03-104680840645, 680840775
16413ee468-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 Capsule
1743d51c1d-5f5b-4b9e-95d0-d12ceff8d84e (view SPL)Tizanidine Hydrochloride Tablets 2 mg and 4 mgprescriptionHuman PrescriptionStat Rx Usa LlcRELABEL, REPACK2012-02-093425490549, 425490597
18449b1b6a-fdf5-4e29-b0a3-a962dbcdf843 (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2013-11-261581180179
194659df31-8b89-4eff-9d86-7b7e38de416b (view SPL)Tizanidine Tablets, LabelThese highlights do not include all the information needed to useSee full prescribing information forInitial U.S. Approval: 1996prescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.MANUFACTURE, PACK2015-08-146576640502, 576640503
204779b047-0dd6-460d-9ec8-5be17ac5d2fa (view SPL)Tizanidine Hydrochloride Tablets 4 mg PHARMACOKINETIC DIFFERENCES BEWTWEEN TIZANIDINE CAPSULES AND TIZANIDINE TABLETS: TIZANIDINE CAPSULES ARE NOT BIOEQUIVALENT TO TIZANIDINE TABLETS IN THE FED STATE. THE PRESCRIBER SHOULD BE THOROUGHLY FAMILIAR WITH THE COMPLEX EFFECTS OF FOOD ON TIZANIDINE PHATMACOKINETICS (see PHARMACOKINETICS and DOSAGE AND ADMINISTRATIONprescriptionHuman PrescriptionAmerican Health PackagingREPACK2013-07-083680840013
2149f50d5e-3738-4f3a-8999-28c6a5ff2cd7 (view SPL)prescriptionHuman PrescriptionCardinal HealthREPACK2013-07-011551546256
224c4de495-8f9c-4b74-8773-fdf6ad7290fc (view SPL)Tizanidine Hydrochloride TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-12-0518552890809
234e2fd72f-4e76-411c-9ab8-441547141b34 (view SPL)These highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.RELABEL, REPACK2013-12-312105440576
244f0d83de-0810-4255-8114-443f8fb915de (view SPL)TIZANIDINE HYDROCHLORIDEprescriptionHuman PrescriptionRebel Distributors Corprelabel, repack2009-12-011216950126, 216950127
2554bd58ee-76f6-44e7-83bb-fe752c3cbf9a (view SPL)TIZANIDINEprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-11-052619190220, 619190221
265a42267f-a400-4bfd-ad7c-fad335884ba8 (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionMedsource Pharmaceuticals2012-08-132458650386
2768d22330-830a-41ea-8c51-c31441c5a451 (view SPL)prescriptionHuman PrescriptionCardinal HealthREPACK2013-07-294551545068
286b6a34e2-4de2-4dd0-adca-40f32f8d854c (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionCardinal HealthREPACK2011-06-211551543487
296d8e0262-5ccf-4447-90dd-f5eec069664c (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionH.J. Harkins Company, Inc.analysis, manufacture2011-12-213529590689, 529590691
3073592fc0-4f9d-4812-81ab-3a8abc89145a (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionRemedyrepack Inc.2014-11-211493490579
3179a0e9fc-589e-46ef-b9da-7aa3665bf1e2 (view SPL)These highlights do not include all the information needed to use tizanidine tablets safely and effectively. See full prescribing information for tizanidine tablets.TIZANIDINE tablets USP, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionMylan Institutional Inc.2014-07-032510790998
3282084f4e-00d0-c298-c13a-88a6c0860b02 (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2002-07-031636293209
3387f8a776-e8ae-4aed-a221-98ca72a2bedf (view SPL)Tizanidine Hydrochloride 4 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcmanufacture, repack2011-12-283428499990347
348c442290-31c1-40ea-aacc-935e85c221d0 (view SPL)Tizanidine Hydrochloride Tablets 2 mg and 4 mgprescriptionHuman PrescriptionMajor2013-08-202009046193
358f427e41-53cc-437e-9169-9242c86d50a5 (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-02-194521250390
36945b3469-b0a6-419e-b95b-d1d3013ccc0c (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-151521250408
37953db236-b848-484f-83b7-436c3a274c88 (view SPL)TIZANIDINE TABLETS, USP 2 mg (base) and 4 mg (base) Rx OnlyprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-011604290241, 604290242
389852284f-0101-4167-81d5-e74732b95e8f (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2012-10-052332610103, 332610104
39988cbeae-64ed-4ce1-b503-f5e7b77f1a2a (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionUnit Dose ServicesREPACK2009-09-302504366755
409c70817f-e721-4f04-b095-0747702df614 (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionAltura Pharmaceuticals, Inc.relabel, repack2010-04-281638740087
419d222859-6697-47bf-98ec-91984002e0d9 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2013-11-223548684939, 548684964
42a1a04baf-cfe0-40e8-817a-a0e17df45123 (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2013-08-133581180180
43a204c899-a892-41db-a96b-45478e5588f2 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-08-212165900220, 165900221
44a3fa9c69-4baf-44f5-bac4-a19c34b0e1cb (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionUnichem Pharmaceuticals (Usa), Inc.2014-02-283293000168
45a42f3479-f2c2-8214-d547-c5cae9bfed1e (view SPL)These highlights do not include all the information needed to use tizanidine hydrochloride safely and effectively. See full prescribing information for tizanidine hydrochloride. Tizanidine Tablets USP, for oral use Initial U.S. Approval: 1996 PHARMACOKINETIC DIFFERENCES BETWEEN TIZANIDINE CAPSULES AND TIZANIDINE TABLETS: TIZANIDINE CAPSULES ARE NOT BIOEQUIVALENT TO TIZANIDINE TABLETS IN THE FED STATE. THE PRESCRIBER SHOULD BE THOROUGHLY FAMILIAR WITH THE COMPLEX EFFECTS OF FOOD ON TIZANIDINE PHARMACOKINETICS (see PHARMACOKINETICS and DOSAGE AND ADMINISTRATION).prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2015-05-209551110179, 551110180
46a9ce2cc9-8a97-4965-bccc-32137eb2911a (view SPL)These highlights do not include all the information needed to use tizanidine tablets safely and effectively. See full prescribing information for tizanidine tablets. TIZANIDINE tablets USP, for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-06-091433530914, 433530946
47ac897a5a-677b-4a6e-abb1-b810470200fc (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use tizanidine hydrochloride safely and effectively. See full prescribing information for tizanidine hydrochloride. Tizanidine Tablets USP, for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2013-12-1011430630455
48b254a0f4-efb1-4874-ae45-1dc5fe316964 (view SPL)TizanidineprescriptionHuman PrescriptionBryant Ranch PrepackANALYSIS, MANUFACTURE, RELABEL, REPACK2002-07-032636291673
49b2e8ab61-db55-4bf2-a7c9-1b74e95e5901 (view SPL)Tizanidine Hydrochloride TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-09-2313552890784
50b4227d39-6f9e-5ded-4169-087ce91a75b5 (view SPL)These highlights do not include all the information needed to use tizanidine tablets safely and effectively. See full prescribing information for tizanidine tablets. TIZANIDINE tablets USP, for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-11-134003780722, 003780724
51b68a9f81-7138-48cf-b987-b8d284e8105a (view SPL)TIZANIDINE HYDROCHLORIDEprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2014-05-203964353560662
52b8650455-26cb-494a-82aa-c8388fdb67ff (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionRemedyrepack Inc.2014-07-141521250390
53ba7420e1-7db3-44b3-be95-369e5cb7cc33 (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-231521250553
54c14fa366-721d-47d1-928a-ae2fb250752d (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionMedsource Pharmaceuticals2012-08-132458650348
55c2353d09-3cb4-486e-8ae7-29339c1ba76b (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-04-301631870009
56cf77e63c-a62a-43fc-8705-0558925e04e8 (view SPL)TIZANIDINE TABLETS, USP 2 mg (base) and 4 mg (base) Rx OnlyprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-07-213631870145
57d0182933-afae-4db4-9aa1-a869dcf39658 (view SPL)Tizanidine Tablets, USP Rx onlyprescriptionHuman PrescriptionNew Horizon Rx Group, LlcMANUFACTURE2013-12-273585170380
58d0d913a9-cfe8-4a7e-b20d-ea51828a01a1 (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionMckesson Contract PackagingREPACK2012-02-271762370252
59d24e0cda-a22f-404f-b861-f85090cef099 (view SPL)These highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionMajor2014-09-222009046418
60d2f5bdfe-0bb2-4c54-953e-a44efe761ae0 (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionSt Marys Medical Park Pharmacymanufacture, relabel, repack2015-08-261607600782
61e0132fe9-b145-4324-9f41-a86fe6ac2b85 (view SPL)These highlights do not include all the information needed to usetizanidine tabletssafely and effectively. See full prescribing information fortizanidine tablets. TIZANIDINE tablets, USP, for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionCorepharma, Llc2014-09-3010647200106, 647200138
62e13b111a-25b7-4fdd-a102-30f2996722f3 (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870493
63e4723fbe-ad87-4d72-9c20-b0621f349dfc (view SPL)These highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-03-262687889497, 687889514
64fc1d0404-e9a8-4682-af4c-b9164d6e36ef (view SPL)Tizanidine Hydrochloride TabletsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcMANUFACTURE, repack2012-01-033446499990584
65fce6f784-cfc5-49ef-af1f-fa6dc389ed3e (view SPL)Tizanidine Tablets USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-02-252687889091, 687889092

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