Application 021137

Type
NDA
Sponsor
GENUS LIFESCIENCES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOLETLEVOTHYROXINE SODIUMTABLET;ORAL0.025MGNoNo
002LEVOLETLEVOTHYROXINE SODIUMTABLET;ORAL0.05MGNoNo
003LEVOLETLEVOTHYROXINE SODIUMTABLET;ORAL0.075MGNoNo
004LEVOLETLEVOTHYROXINE SODIUMTABLET;ORAL0.088MGNoNo
005LEVOLETLEVOTHYROXINE SODIUMTABLET;ORAL0.1MGNoNo
006LEVOLETLEVOTHYROXINE SODIUMTABLET;ORAL0.112MGNoNo
007LEVOLETLEVOTHYROXINE SODIUMTABLET;ORAL0.125MGNoNo
008LEVOLETLEVOTHYROXINE SODIUMTABLET;ORAL0.137MGNoNo
009LEVOLETLEVOTHYROXINE SODIUMTABLET;ORAL0.15MGNoNo
010LEVOLETLEVOTHYROXINE SODIUMTABLET;ORAL0.175MGNoNo
011LEVOLETLEVOTHYROXINE SODIUMTABLET;ORAL0.2MGNoNo
012LEVOLETLEVOTHYROXINE SODIUMTABLET;ORAL0.3MGNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71742SUPPL2022-08-08
69712SUPPL2021-12-21
69711SUPPL2021-12-21
69710SUPPL2021-12-21
69632SUPPL2021-12-19
69631SUPPL2021-12-19
69630SUPPL2021-12-19
14481ORIG2004-06-08
41978ORIG2004-06-04
26884ORIG2003-06-08