ANDA 090600

LANNETT CO INC

FDA Drug Application

Application #090600

Documents

• Label: 2009-10-21
• Letter: 2009-10-14

Application Sponsors

ANDA 090600

LANNETT CO INC

Marketing Status

• Over-the-counter: 001
• Over-the-counter: 002

Application Products

001	FOR SOLUTION;ORAL	17GM/PACKET	0	GLYCOLAX	POLYETHYLENE GLYCOL 3350
002	FOR SOLUTION;ORAL	17GM/SCOOPFUL	0	GLYCOLAX	POLYETHYLENE GLYCOL 3350

FDA Submissions

	ORIG	1	AP	2009-10-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2011-10-21
LABELING; Labeling	SUPPL	7	AP	2012-06-07

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15
SUPPL	7	Null	15

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90600
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYCOLAX","activeIngredients":"POLYETHYLENE GLYCOL 3350","strength":"17GM\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"GLYCOLAX","activeIngredients":"POLYETHYLENE GLYCOL 3350","strength":"17GM\/SCOOPFUL","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/06\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/090600s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"GLYCOLAX","submission":"POLYETHYLENE GLYCOL 3350","actionType":"17GM\/PACKET","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"GLYCOLAX","submission":"POLYETHYLENE GLYCOL 3350","actionType":"17GM\/SCOOPFUL","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2009-10-06
        )

)