ACCORD HLTHCARE FDA Approval ANDA 212399

ANDA 212399

ACCORD HLTHCARE

FDA Drug Application

Application #212399

Application Sponsors

ANDA 212399ACCORD HLTHCARE

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; ORIG1AP2020-10-19STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB2
002PrescriptionAB2
003PrescriptionAB2
004PrescriptionAB2
005PrescriptionAB2
006PrescriptionAB2
007PrescriptionAB2
008PrescriptionAB2
009PrescriptionAB2
010PrescriptionAB2
011PrescriptionAB2
012PrescriptionAB2

CDER Filings

ACCORD HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212399
            [companyName] => ACCORD HLTHCARE
            [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":"10\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-19
        )

)

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