NDA 022497

ALVOGEN

FDA Drug Application

Application #022497

Documents

• Label: 2014-07-22
• Summary Review: 2012-07-06
• Letter: 2011-11-17
• Letter: 2014-07-21
• Label: 2011-11-16
• Review: 2012-07-06
• Label: 2016-08-30
• Label: 2017-05-08
• Medication Guide: 2017-05-08
• Letter: 2017-05-09
• Letter: 2019-12-11
• Label: 2019-12-11
• Medication Guide: 2019-12-11

Application Sponsors

NDA 022497

ALVOGEN

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

450MG

1

FORFIVO XL

BUPROPION HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2011-11-10	STANDARD
LABELING; Labeling	SUPPL	2	AP	2014-07-17	901 REQUIRED
LABELING; Labeling	SUPPL	3	AP	2016-08-30	STANDARD
LABELING; Labeling	SUPPL	4	AP	2017-05-04	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-12-10	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6
SUPPL	3	Null	6
SUPPL	4	Null	7
SUPPL	8	Null	33

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22497
            [companyName] => ALVOGEN
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/022497s008lbl.pdf#page=33"]
            [products] => [{"drugName":"FORFIVO XL","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"450MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/10\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022497s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/04\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022497s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/04\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022497s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022497s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022497s003lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022497s002lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022497s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FORFIVO XL","submission":"BUPROPION HYDROCHLORIDE","actionType":"450MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-12-10
        )

)