FDA.reportPublic FDA data

Application 208749

Type
ANDA
Sponsor
MAIA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMPOWDER;INTRAVENOUS100MCG/VIALNoNo
002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMPOWDER;INTRAVENOUS200MCG/VIALNoNo
003LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMPOWDER;INTRAVENOUS500MCG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70511-111Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSMAIA Pharmaceuticals, Inc.ANDACurrent
70511-112Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSMAIA Pharmaceuticals, Inc.ANDACurrent
70511-113Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSMAIA Pharmaceuticals, Inc.ANDACurrent
70860-451Levothyroxine Sodiumlevothyroxine sodium anhydrousAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-452Levothyroxine Sodiumlevothyroxine sodium anhydrousAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-453Levothyroxine Sodiumlevothyroxine sodium anhydrousAthenex Pharmaceutical Division, LLC.ANDACurrent