FDA.reportPublic FDA data

Application 206163

Type
ANDA
Sponsor
PIRAMAL CRITICAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMPOWDER;INTRAVENOUS100MCG/VIALNoNo
002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMPOWDER;INTRAVENOUS500MCG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66794-200Levothyroxine SodiumLevothyroxine SodiumPiramal Critical Care, Inc.ANDACurrent
66794-200Levothyroxine SodiumLevothyroxine SodiumPiramal Critical Care, Inc.ANDACurrent
66794-200Levothyroxine SodiumLevothyroxine SodiumPiramal Critical Care, Inc.ANDACurrent
66794-201Levothyroxine SodiumLevothyroxine SodiumPiramal Critical Care, Inc.ANDACurrent
66794-201Levothyroxine SodiumLevothyroxine SodiumPiramal Critical Care, Inc.ANDACurrent
66794-201Levothyroxine SodiumLevothyroxine SodiumPiramal Critical Care, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
40527ORIG2016-07-18
32784ORIG2016-07-01