ANDA 040418

MALLINCKRODT

FDA Drug Application

Application #040418

Documents

• Letter: 2001-06-27
• Label: 2001-06-27
• Review: 2001-06-27

Application Sponsors

ANDA 040418

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

500MG/15ML;7.5MG/15ML

0

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	2001-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2008-03-20

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40418
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG\/15ML;7.5MG\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/27\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2001\\\/40-418_Hydrocdone%20.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG\/15ML;7.5MG\/15ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2001-06-27
        )

)