ABBVIE FDA Approval ANDA 071295

ANDA 071295

ABBVIE

FDA Drug Application

Application #071295

Application Sponsors

ANDA 071295ABBVIE

Marketing Status

Discontinued001

Application Products

001SOLUTION;INTRAMUSCULAREQ 2MG SULFATE/0.7ML0ATROPINEATROPINE

FDA Submissions

ORIG1AP1987-01-30
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1988-06-10
LABELING; LabelingSUPPL3AP1988-06-10
LABELING; LabelingSUPPL4AP1988-07-26
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1989-01-11
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1991-01-16
LABELING; LabelingSUPPL7AP1991-01-16

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null1

CDER Filings

ABBVIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71295
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROPINE","activeIngredients":"ATROPINE","strength":"EQ 2MG SULFATE\/0.7ML","dosageForm":"SOLUTION;INTRAMUSCULAR","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATROPINE","submission":"ATROPINE","actionType":"EQ 2MG SULFATE\/0.7ML","submissionClassification":"SOLUTION;INTRAMUSCULAR","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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