FDA.reportPublic FDA data

Application 021301

Type
NDA
Sponsor
KING PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOXYLLEVOTHYROXINE SODIUMTABLET;ORAL0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumYesNo
002LEVOXYLLEVOTHYROXINE SODIUMTABLET;ORAL0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumYesNo
003LEVOXYLLEVOTHYROXINE SODIUMTABLET;ORAL0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumYesNo
004LEVOXYLLEVOTHYROXINE SODIUMTABLET;ORAL0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumYesNo
005LEVOXYLLEVOTHYROXINE SODIUMTABLET;ORAL0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumYesNo
006LEVOXYLLEVOTHYROXINE SODIUMTABLET;ORAL0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumYesNo
007LEVOXYLLEVOTHYROXINE SODIUMTABLET;ORAL0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumYesNo
008LEVOXYLLEVOTHYROXINE SODIUMTABLET;ORAL0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumYesNo
009LEVOXYLLEVOTHYROXINE SODIUMTABLET;ORAL0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumYesNo
010LEVOXYLLEVOTHYROXINE SODIUMTABLET;ORAL0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumYesNo
011LEVOXYLLEVOTHYROXINE SODIUMTABLET;ORAL0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumYesYes
012LEVOXYLLEVOTHYROXINE SODIUMTABLET;ORAL0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60793-850LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-850LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-850LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-851LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-851LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-851LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-852LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-852LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-852LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-853LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-853LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-853LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-854LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-854LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-854LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-855LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-855LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-855LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-856LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-856LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-856LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-857LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-857LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-857LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-858LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-858LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-858LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-859LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-859LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-859LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-860LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-860LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
60793-860LEVOXYLlevothyroxine sodiumPfizer Laboratories Div Pfizer IncNDACurrent
66336-600LEVOXYLLEVOTHYROXINE SODIUMDispensing Solutions, Inc.NDACurrent
66336-601LEVOXYLLEVOTHYROXINE SODIUMDispensing Solutions, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56986SUPPL2018-12-21
15135SUPPL2011-03-21
21581SUPPL2011-02-15
4964SUPPL2008-07-10
15134SUPPL2008-07-09
36610SUPPL2005-03-10
27416SUPPL2005-03-10
27415SUPPL2003-08-06
4963SUPPL2002-07-17
21580ORIG2002-01-07
36609ORIG2001-05-25
4962ORIG2001-05-25