ANDA 202310

LANNETT CO INC

FDA Drug Application

Application #202310

Documents

• Letter: 2015-11-03

Application Sponsors

ANDA 202310

LANNETT CO INC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

20MG/5ML

0

MORPHINE SULFATE

MORPHINE SULFATE

FDA Submissions

	ORIG	1	AP	2015-10-30
REMS; REMS	SUPPL	2	AP	2018-09-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-02-10	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	15
SUPPL	3	Null	15

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202310
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"20MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/30\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202310Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/10\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-2","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/10\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-10
        )

)