FDA.reportPublic FDA data

Application 021447

Type
NDA
Sponsor
COVIS PHARMA BV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZANAFLEXTIZANIDINE HYDROCHLORIDECAPSULE;ORALEQ 2MG BASEYesNo
002ZANAFLEXTIZANIDINE HYDROCHLORIDECAPSULE;ORALEQ 4MG BASEYesNo
003ZANAFLEXTIZANIDINE HYDROCHLORIDECAPSULE;ORALEQ 6MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-2788tizanidine hydrochloridetizanidine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2788tizanidine hydrochloridetizanidine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2788tizanidine hydrochloridetizanidine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2788tizanidine hydrochloridetizanidine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2788tizanidine hydrochloridetizanidine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2789tizanidine hydrochloridetizanidine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2789tizanidine hydrochloridetizanidine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2789tizanidine hydrochloridetizanidine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2789tizanidine hydrochloridetizanidine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2789tizanidine hydrochloridetizanidine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2790tizanidine hydrochloridetizanidine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2790tizanidine hydrochloridetizanidine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2790tizanidine hydrochloridetizanidine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2790tizanidine hydrochloridetizanidine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2790tizanidine hydrochloridetizanidine hydrochlorideActavis Pharma, Inc.NDACurrent
10144-602Zanaflextizanidine hydrochlorideAcorda Therapeutics, Inc.NDACurrent
10144-604Zanaflextizanidine hydrochlorideAcorda Therapeutics, Inc.NDACurrent
10144-606Zanaflextizanidine hydrochlorideAcorda Therapeutics, Inc.NDACurrent
21695-373Zanaflextizanidine hydrochlorideRebel Distributors CorpNDACurrent
55700-259tizanidine hydrochloridetizanidine hydrochlorideLake Erie Medical DBA Quality Care Products LLCNDACurrent
55700-259tizanidine hydrochloridetizanidine hydrochlorideLake Erie Medical DBA Quality Care Products LLCNDACurrent
63629-5139tizanidine hydrochloridetizanidine hydrochlorideBryant Ranch PrepackNDACurrent
63629-5139tizanidine hydrochloridetizanidine hydrochlorideBryant Ranch PrepackNDACurrent
70515-602Zanaflextizanidine hydrochlorideCovis Pharma US, IncNDACurrent
70515-602Zanaflextizanidine hydrochlorideCovis PharmaNDACurrent
70515-602Zanaflextizanidine hydrochlorideCovis PharmaNDACurrent
70515-604Zanaflextizanidine hydrochlorideCovis Pharma US, IncNDACurrent
70515-604Zanaflextizanidine hydrochlorideCovis PharmaNDACurrent
70515-604Zanaflextizanidine hydrochlorideCovis PharmaNDACurrent
70515-606Zanaflextizanidine hydrochlorideCovis Pharma US, IncNDACurrent
70515-606Zanaflextizanidine hydrochlorideCovis PharmaNDACurrent
70515-606Zanaflextizanidine hydrochlorideCovis PharmaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80332SUPPL 2025-01-21
80433SUPPL 2024-11-26
65690SUPPL2020-12-22
65669SUPPL2020-12-22
36966SUPPL2013-11-08
27827SUPPL2013-11-08
5419SUPPL2013-03-11
15505SUPPL2006-08-04
5418SUPPL2006-08-04
21667ORIG2004-03-24
27826ORIG2003-05-30
15504ORIG2002-08-29