Application 214047

Type
NDA
Sponsor
REGULIANCE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THYQUIDITYLEVOTHYROXINE SODIUMSOLUTION; ORAL100MCG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66689-105THYQUIDITYLevothyroxine SodiumVistaPharm, Inc.NDACurrent
66689-105THYQUIDITYLevothyroxine SodiumVistaPharm, Inc.NDACurrent
66689-105THYQUIDITYLevothyroxine SodiumVistaPharm, Inc.NDACurrent
81116-100THYQUIDITYLevothyroxine SodiumGALENICA S.A.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68013ORIG2021-07-06
65497ORIG2020-12-04
65441ORIG2020-12-01