ANDA 090477

LANNETT CO INC

FDA Drug Application

Application #090477

Application Sponsors

ANDA 090477

LANNETT CO INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

EQ 5MG BASE/5ML

0

ESCITALOPRAM OXALATE

ESCITALOPRAM OXALATE

FDA Submissions

	ORIG	1	AP	2013-06-12
LABELING; Labeling	SUPPL	3	AP	2015-10-23	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-09-08	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-09-08	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-09-08	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-09-21	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	15

TE Codes

001

Prescription

AA

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90477
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 5MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESCITALOPRAM OXALATE","submission":"ESCITALOPRAM OXALATE","actionType":"EQ 5MG BASE\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)