ANDA 078281

LANNETT CO INC

FDA Drug Application

Application #078281

Application Sponsors

ANDA 078281

LANNETT CO INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, DELAYED RELEASE;ORAL	EQ 20MG BASE	0	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM
002	TABLET, DELAYED RELEASE;ORAL	EQ 40MG BASE	0	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM

FDA Submissions

	ORIG	1	AP	2011-01-20
LABELING; Labeling	SUPPL	6	AP	2014-08-05
LABELING; Labeling	SUPPL	8	AP	2012-01-17
LABELING; Labeling	SUPPL	10	AP	2012-01-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2012-05-18
LABELING; Labeling	SUPPL	12	AP	2013-05-24	STANDARD
LABELING; Labeling	SUPPL	13	AP	2013-05-24	STANDARD
LABELING; Labeling	SUPPL	15	AP	2013-12-10	STANDARD
LABELING; Labeling	SUPPL	16	AP	2014-12-10	STANDARD
LABELING; Labeling	SUPPL	17	AP	2015-04-08	STANDARD
LABELING; Labeling	SUPPL	19	AP	2020-01-03	STANDARD
LABELING; Labeling	SUPPL	21	AP	2020-01-03	STANDARD
LABELING; Labeling	SUPPL	22	AP	2020-01-03	STANDARD
LABELING; Labeling	SUPPL	23	AP	2020-01-03	STANDARD
LABELING; Labeling	SUPPL	24	AP	2020-01-03	STANDARD
LABELING; Labeling	SUPPL	29	AP	2022-01-21	STANDARD
LABELING; Labeling	SUPPL	30	AP	2022-01-21	STANDARD
LABELING; Labeling	SUPPL	32	AP	2022-06-09	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	8
SUPPL	8	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	15
SUPPL	15	Null	15
SUPPL	16	Null	7
SUPPL	17	Null	7
SUPPL	19	Null	7
SUPPL	21	Null	7
SUPPL	22	Null	7
SUPPL	23	Null	15
SUPPL	24	Null	15
SUPPL	29	Null	31
SUPPL	30	Null	15
SUPPL	32	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78281
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 20MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 40MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PANTOPRAZOLE SODIUM","submission":"PANTOPRAZOLE SODIUM","actionType":"EQ 20MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PANTOPRAZOLE SODIUM","submission":"PANTOPRAZOLE SODIUM","actionType":"EQ 40MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)