SPECGX LLC FDA Approval ANDA 040419

ANDA 040419

SPECGX LLC

FDA Drug Application

Application #040419

Documents

Letter2001-05-31

Application Sponsors

ANDA 040419SPECGX LLC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL300MG;15MG0ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE
002TABLET;ORAL300MG;30MG0ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE
003TABLET;ORAL300MG;60MG0ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE

FDA Submissions

ORIG1AP2001-05-31
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2002-12-13
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2002-12-13
LABELING; LabelingSUPPL4AP2002-12-13
LABELING; LabelingSUPPL10AP2007-11-30
LABELING; LabelingSUPPL11AP2008-02-21
LABELING; LabelingSUPPL12AP2011-06-22
LABELING; LabelingSUPPL14AP2013-05-10STANDARD
LABELING; LabelingSUPPL16AP2013-10-18STANDARD
LABELING; LabelingSUPPL17AP2016-12-16STANDARD
LABELING; LabelingSUPPL19AP2016-12-16STANDARD
LABELING; LabelingSUPPL21AP2018-04-06STANDARD
LABELING; LabelingSUPPL23AP2018-04-06STANDARD
REMS; REMSSUPPL24AP2018-09-18
LABELING; LabelingSUPPL25AP2018-09-20STANDARD
LABELING; LabelingSUPPL26AP2019-10-07STANDARD
LABELING; LabelingSUPPL29AP2021-03-04STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL12Null7
SUPPL14Null7
SUPPL16Null7
SUPPL17Null15
SUPPL19Null7
SUPPL21Null7
SUPPL23Null7
SUPPL24Null7
SUPPL25Null15
SUPPL26Null15
SUPPL29Null7

TE Codes

001PrescriptionAA
002PrescriptionAA
003PrescriptionAA

CDER Filings

SPECGX LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40419
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;60MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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