FDA.reportPublic FDA data

Application 205919

Type
NDA
Sponsor
NOVA LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PURIXANMERCAPTOPURINESUSPENSION;ORAL20MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62484-0020PURIXANPurixanNova Laboratories, LtdNDACurrent
62484-0020PURIXANPurixanNova Laboratories, LtdNDACurrent
62484-0020PURIXANPurixanNova Laboratories, LtdNDACurrent
62484-0020PURIXANPurixanNova Laboratories, LtdNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79976SUPPL 2024-10-25
79971SUPPL 2024-10-24
79071SUPPL 2024-07-15
79037SUPPL 2024-07-10
62589SUPPL2020-04-17
62480SUPPL2020-04-08
52727SUPPL2018-02-26
52692SUPPL2018-02-23
48348SUPPL2017-05-10
48319SUPPL2017-05-09
10532SUPPL2014-12-31
23010ORIG2014-12-18
10531ORIG2014-04-29
40520ORIG2014-04-28