ANDA 202309

LANNETT CO INC

FDA Drug Application

Application #202309

Documents

• Letter: 2015-11-30
• Label: 2015-12-11

Application Sponsors

ANDA 202309

LANNETT CO INC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

10MG/5ML

0

MORPHINE SULFATE

MORPHINE SULFATE

FDA Submissions

	ORIG	1	AP	2015-11-25
REMS; REMS	SUPPL	2	AP	2018-09-18	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	15

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202309
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"10MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/25\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202309Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/25\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202309Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202309Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-2","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)