FDA.reportPublic FDA data

Application 210632

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMSOLUTION;INTRAVENOUS100MCG/5ML (20MCG/ML)YesYes
002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMSOLUTION;INTRAVENOUS200MCG/5ML (40MCG/ML)YesYes
003LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMSOLUTION;INTRAVENOUS500MCG/5ML (100MCG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-885Levothyroxine SodiumLevothyroxine SodiumFresenius Kabi USA, LLCNDACurrent
63323-885Levothyroxine SodiumLevothyroxine SodiumFresenius Kabi USA, LLCNDACurrent
63323-885Levothyroxine SodiumLevothyroxine SodiumFresenius Kabi USA, LLCNDACurrent
63323-890Levothyroxine SodiumLevothyroxine SodiumFresenius Kabi USA, LLCNDACurrent
63323-895Levothyroxine SodiumLevothyroxine SodiumFresenius Kabi USA, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61318ORIG2019-12-17
61317ORIG2019-12-17
58297ORIG2019-04-12
58296ORIG2019-04-12