ANDA 206674

INVAGEN PHARMS

FDA Drug Application

Application #206674

Documents

• Letter: 2016-02-12

Application Sponsors

ANDA 206674

INVAGEN PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	100MG	0	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	150MG	0	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	200MG	0	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-02-09	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-01-04	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-01-04	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-01-04	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7
SUPPL	10	Null	7
SUPPL	13	Null	15

TE Codes

001	Prescription	AB1
002	Prescription	AB1
003	Prescription	AB1

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206674
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/09\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206674Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/04\/2021","submission":"SUPPL-13","supplementCategories":"Labeling-Medication Guide, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/04\/2021","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/04\/2021","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-01-04
        )

)