ANDA 079244

LANNETT CO INC

FDA Drug Application

Application #079244

Documents

• Label: 2009-05-07
• Letter: 2009-05-05

Application Sponsors

ANDA 079244

LANNETT CO INC

Marketing Status

• Prescription: 001

Application Products

001

CONCENTRATE;ORAL

2MG/ML

0

LORAZEPAM

LORAZEPAM

FDA Submissions

	ORIG	1	AP	2009-04-28
LABELING; Labeling	SUPPL	5	AP	2016-07-06	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	5	Null	15

TE Codes

001

Prescription

AA

CDER Filings

LANNETT CO INC

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(
    [0] => Array
        (
            [ApplNo] => 79244
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORAZEPAM","activeIngredients":"LORAZEPAM","strength":"2MG\/ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/28\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/079244lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LORAZEPAM","submission":"LORAZEPAM","actionType":"2MG\/ML","submissionClassification":"CONCENTRATE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2009-04-28
        )

)