ANDA 090678

LANNETT CO INC

FDA Drug Application

Application #090678

Documents

• Letter: 2013-11-12
• Label: 2013-11-19

Application Sponsors

ANDA 090678

LANNETT CO INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

20MG

0

RABEPRAZOLE SODIUM

RABEPRAZOLE SODIUM

FDA Submissions

	ORIG	1	AP	2013-11-08
LABELING; Labeling	SUPPL	3	AP	2015-04-03	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-04-03	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-02-07	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-02-07	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-02-07	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-02-07	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	10	Null	15

TE Codes

001

Prescription

AB

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90678
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RABEPRAZOLE SODIUM","activeIngredients":"RABEPRAZOLE SODIUM","strength":"20MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/08\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/090678Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"RABEPRAZOLE SODIUM","submission":"RABEPRAZOLE SODIUM","actionType":"20MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2013-11-08
        )

)