FDA.reportPublic FDA data

Application 209713

Type
ANDA
Sponsor
LUPIN ATLANTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
003LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
004LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
005LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
006LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
007LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
008LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
009LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
010LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
011LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
012LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6949Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
0904-6949Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
0904-6950Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
0904-6950Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
0904-6951Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
0904-6951Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
0904-6952Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
0904-6952Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
0904-6953Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
0904-6953Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
0904-6954Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
0904-6954Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
0904-6955Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
0904-6955Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
0904-6956Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
0904-6956Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
0904-6957Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
0904-6957Levothyroxine SodiumLevothyroxine SodiumMajor PharmaceuticalsANDACurrent
50090-4947Levothyroxine SodiumLevothyroxine SodiumA-S Medication SolutionsANDACurrent
50090-4947Levothyroxine SodiumLevothyroxine SodiumA-S Medication SolutionsANDACurrent
50090-4951Levothyroxine SodiumLevothyroxine SodiumA-S Medication SolutionsANDACurrent
50090-4951Levothyroxine SodiumLevothyroxine SodiumA-S Medication SolutionsANDACurrent
50090-5133Levothyroxine SodiumLevothyroxine SodiumA-S Medication SolutionsANDACurrent
50090-5792Levothyroxine SodiumLevothyroxine SodiumA-S Medication SolutionsANDACurrent
51655-479Levothyroxine SodiumLevothyroxine SodiumNorthwind Pharmaceuticals, LLCANDACurrent
51655-528Levothyroxine SodiumLevothyroxine SodiumNorthwind Pharmaceuticals, LLCANDACurrent
51655-923Levothyroxine SodiumLevothyroxine SodiumNorthwind PharmaceuticalsANDACurrent
51655-924Levothyroxine SodiumLevothyroxine SodiumNorthwind PharmaceuticalsANDACurrent
51655-985Levothyroxine SodiumLevothyroxine SodiumNorthwind PharmaceuticalsANDACurrent
51655-989Levothyroxine SodiumLevothyroxine SodiumNorthwind PharmaceuticalsANDACurrent
55154-3558Levothyroxine SodiumLevothyroxine SodiumCardinal HealthANDACurrent
55154-3559Levothyroxine SodiumLevothyroxine SodiumCardinal HealthANDACurrent
55154-3560Levothyroxine SodiumLevothyroxine SodiumCardinal HealthANDACurrent
55154-3561Levothyroxine SodiumLevothyroxine SodiumCardinal HealthANDACurrent
55154-3562Levothyroxine SodiumLevothyroxine SodiumCardinal HealthANDACurrent
55154-3563Levothyroxine SodiumLevothyroxine SodiumCardinal HealthANDACurrent
60687-453Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-453Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-453Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-453Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-464Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-464Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-464Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-464Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-475Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-475Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-475Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-475Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-486Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-486Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-486Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-486Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-497Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-497Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-497Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-497Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-508Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-508Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-508Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-508Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-519Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-519Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-519Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-519Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-530Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-530Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-530Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-530Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-541Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-541Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-541Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-541Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-552Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-552Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-552Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-563Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-563Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
60687-563Levothyroxine SodiumLevothyroxine SodiumAmerican Health PackagingANDACurrent
68180-965Levothyroxine SodiumLevothyroxine SodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-965Levothyroxine SodiumLevothyroxine SodiumLupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71492SUPPL2022-06-30