FDA.reportPublic FDA data

Application 017821

Type
NDA
Sponsor
JANSSEN RES AND DEV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLEXERILCYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002FLEXERILCYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33354SUPPL2013-04-16
13912SUPPL2013-04-16
40761SUPPL2008-04-02
13911SUPPL2004-06-04
33353SUPPL2003-03-05