SPECGX LLC FDA Approval ANDA 040400

ANDA 040400

SPECGX LLC

FDA Drug Application

Application #040400

Documents

Letter2000-07-26

Application Sponsors

ANDA 040400SPECGX LLC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL325MG;10MG0HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

ORIG1AP2000-07-26
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2002-08-16
LABELING; LabelingSUPPL3AP2003-01-22
LABELING; LabelingSUPPL6AP2003-10-21
LABELING; LabelingSUPPL10AP2004-12-14
LABELING; LabelingSUPPL12AP2006-03-27
LABELING; LabelingSUPPL15AP2010-09-15
LABELING; LabelingSUPPL16AP2011-06-24
LABELING; LabelingSUPPL20AP2013-10-25STANDARD
LABELING; LabelingSUPPL23AP2016-12-16STANDARD
LABELING; LabelingSUPPL24AP2016-12-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2017-03-20UNKNOWN
REMS; REMSSUPPL27AP2018-09-18
LABELING; LabelingSUPPL28AP2018-09-20STANDARD
LABELING; LabelingSUPPL30AP2019-10-11STANDARD
LABELING; LabelingSUPPL33AP2021-03-04STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL16Null7
SUPPL20Null15
SUPPL23Null7
SUPPL24Null15
SUPPL25Null15
SUPPL27Null15
SUPPL28Null15
SUPPL30Null15
SUPPL33Null7

TE Codes

001PrescriptionAA

CDER Filings

SPECGX LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40400
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"325MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"325MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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