ANDA 091342

LANNETT CO INC

FDA Drug Application

Application #091342

Application Sponsors

ANDA 091342

LANNETT CO INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

EQ 4MG BASE/5ML

0

ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2011-01-27
LABELING; Labeling	SUPPL	3	AP	2015-01-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2016-03-03	UNKNOWN
LABELING; Labeling	SUPPL	5	AP	2018-03-14	STANDARD
LABELING; Labeling	SUPPL	6	AP	2018-03-14	STANDARD
LABELING; Labeling	SUPPL	8	AP	2022-06-23	STANDARD
	SUPPL	27	AP	2011-01-27

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	8	Null	7
SUPPL	27	Null	0

TE Codes

001

Prescription

AA

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91342
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ONDANSETRON HYDROCHLORIDE","activeIngredients":"ONDANSETRON HYDROCHLORIDE","strength":"EQ 4MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ONDANSETRON HYDROCHLORIDE","submission":"ONDANSETRON HYDROCHLORIDE","actionType":"EQ 4MG BASE\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)