FDA.reportPublic FDA data

Application 017830

Type
NDA
Sponsor
ATON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LODOSYNCARBIDOPATABLET;ORAL25MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25010-711LodosyncarbidopaBausch Health US, LLCNDACurrent
25010-711LodosyncarbidopaAton Pharma, IncNDACurrent
25010-711LodosyncarbidopaBausch Health US, LLCNDACurrent
25010-711LodosyncarbidopaAton Pharma, IncNDACurrent
25010-711LodosyncarbidopaBausch Health US, LLCNDACurrent
68682-200CarbidopaCarbidopa TabletsOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-200CarbidopaCarbidopa TabletsOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-200CarbidopaCarbidopa TabletsOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33357SUPPL2014-02-25
33356SUPPL2014-02-25
13916SUPPL2014-02-25
13915SUPPL2014-02-25
13914SUPPL2014-02-25
11073SUPPL2014-02-25
11072SUPPL2014-02-25
11071SUPPL2014-02-25
11070SUPPL2014-02-25
718SUPPL2014-02-25
717SUPPL2014-02-25
716SUPPL2014-02-25