ANDA 077629

LANNETT CO INC

FDA Drug Application

Application #077629

Documents

• Other Important Information from FDA: 2006-06-19

Application Sponsors

ANDA 077629

LANNETT CO INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

EQ 10MG BASE/5ML

0

CITALOPRAM HYDROBROMIDE

CITALOPRAM HYDROBROMIDE

FDA Submissions

	ORIG	1	AP	2006-06-14
LABELING; Labeling	SUPPL	2	AP	2007-07-02
LABELING; Labeling	SUPPL	3	AP	2008-07-02
LABELING; Labeling	SUPPL	4	AP	2009-03-11
LABELING; Labeling	SUPPL	5	AP	2012-05-21
LABELING; Labeling	SUPPL	7	AP	2013-11-01	STANDARD
LABELING; Labeling	SUPPL	8	AP	2013-11-01	STANDARD
LABELING; Labeling	SUPPL	11	AP	2014-07-17	STANDARD
LABELING; Labeling	SUPPL	13	AP	2017-01-04	STANDARD
LABELING; Labeling	SUPPL	14	AP	2021-09-13	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-09-13	STANDARD
LABELING; Labeling	SUPPL	16	AP	2021-09-21	STANDARD

Submissions Property Types

SUPPL	5	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	11	Null	15
SUPPL	13	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	7
SUPPL	16	Null	7

TE Codes

001

Prescription

AA

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77629
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CITALOPRAM HYDROBROMIDE","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 10MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CITALOPRAM HYDROBROMIDE","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 10MG BASE\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)