Application 214253

Type
NDA
Sponsor
CUSTOPHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMSOLUTION;INTRAVENOUS100MCG/MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24201-002Levothyroxine SodiumLEVOTHYROXINE SODIUMHikma Pharmaceuticals USA Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68964ORIG2021-10-12
67540ORIG2021-05-18
67535ORIG2021-05-18