MACLEODS PHARMS LTD FDA Approval ANDA 211417

ANDA 211417

MACLEODS PHARMS LTD

FDA Drug Application

Application #211417

Application Sponsors

ANDA 211417MACLEODS PHARMS LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007
Prescription008
Prescription009
Prescription010
Prescription011
Prescription012

Application Products

001TABLET;ORAL0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
002TABLET;ORAL0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
003TABLET;ORAL0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
004TABLET;ORAL0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
005TABLET;ORAL0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
006TABLET;ORAL0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
007TABLET;ORAL0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
008TABLET;ORAL0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
009TABLET;ORAL0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
010TABLET;ORAL0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
011TABLET;ORAL0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
012TABLET;ORAL0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2022-12-21STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB1
002PrescriptionAB1
003PrescriptionAB1
004PrescriptionAB1
005PrescriptionAB1
006PrescriptionAB1
007PrescriptionAB1
008PrescriptionAB1
009PrescriptionAB1
010PrescriptionAB1
011PrescriptionAB1
012PrescriptionAB1

CDER Filings

MACLEODS PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211417
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/21\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-21
        )

)

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