ANDA 091238

LANNETT CO INC

FDA Drug Application

Application #091238

Application Sponsors

ANDA 091238

LANNETT CO INC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

120MG/5ML;12MG/5ML

0

ACETAMINOPHEN AND CODEINE PHOSPHATE

ACETAMINOPHEN; CODEINE PHOSPHATE

FDA Submissions

	ORIG	1	AP	2011-11-10
LABELING; Labeling	SUPPL	4	AP	2013-06-27	STANDARD
LABELING; Labeling	SUPPL	5	AP	2013-06-27	STANDARD
LABELING; Labeling	SUPPL	7	AP	2013-10-18	STANDARD
LABELING; Labeling	SUPPL	8	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	9	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	10	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	11	AP	2017-08-29	STANDARD
LABELING; Labeling	SUPPL	12	AP	2017-08-29	STANDARD
LABELING; Labeling	SUPPL	13	AP	2018-02-21	STANDARD
LABELING; Labeling	SUPPL	14	AP	2018-02-21	STANDARD
REMS; REMS	SUPPL	15	AP	2018-09-18	STANDARD
LABELING; Labeling	SUPPL	16	AP	2018-09-21	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-10-07	STANDARD
LABELING; Labeling	SUPPL	19	AP	2021-03-04	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	7
SUPPL	15	Null	15
SUPPL	16	Null	15
SUPPL	17	Null	15
SUPPL	19	Null	15

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91238
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"120MG\/5ML;12MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"120MG\/5ML;12MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)