FDA.reportPublic FDA data

Application 020397

Type
NDA
Sponsor
COVIS PHARMA BV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZANAFLEXTIZANIDINE HYDROCHLORIDETABLET;ORALEQ 4MG BASEYesYes
002ZANAFLEXTIZANIDINE HYDROCHLORIDETABLET;ORALEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10144-594Zanaflextizanidine hydrochlorideAcorda Therapeutics, Inc.NDACurrent
55289-612Zanaflextizanidine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-612Zanaflextizanidine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-612Zanaflextizanidine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
70515-594Zanaflextizanidine hydrochlorideCovis Pharma US, IncNDACurrent
70515-594Zanaflextizanidine hydrochlorideCovis PharmaNDACurrent
70515-594Zanaflextizanidine hydrochlorideCovis PharmaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80331SUPPL 2025-01-21
80432SUPPL 2024-11-26
78621SUPPL 2024-06-04
78610SUPPL 2024-06-03
24904SUPPL2013-11-08
12535SUPPL2013-11-08
24903SUPPL2013-03-21
41331SUPPL2007-07-09
12534SUPPL2006-08-04
2474SUPPL2006-08-04
24902SUPPL2002-11-27
57447ORIG1997-04-11