Application 208711

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EGATENTRICLABENDAZOLETABLET;ORAL250MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0937EGATENtriclabendazoleNovartis Pharmaceuticals CorporationNDACurrent
0078-0937EGATENtriclabendazoleNovartis Pharmaceuticals CorporationNDACurrent
0078-0937EGATENtriclabendazoleNovartis Pharmaceuticals CorporationNDACurrent
0078-0937EGATENtriclabendazoleNovartis Pharmaceuticals CorporationNDACurrent
0078-0937EGATENtriclabendazoleNovartis Pharmaceuticals CorporationNDACurrent
0078-0937EGATENtriclabendazoleNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70203SUPPL2022-02-22
70188SUPPL2022-02-18
57949ORIG2019-03-11
57586ORIG2019-02-27
57604ORIG2019-02-14