ANDA 202304

PRINSTON INC

FDA Drug Application

Application #202304

Application Sponsors

ANDA 202304

PRINSTON INC

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	2015-05-26
LABELING; Labeling	SUPPL	4	AP	2017-12-14	STANDARD
LABELING; Labeling	SUPPL	9	AP	2017-12-14	STANDARD
LABELING; Labeling	SUPPL	10	AP	2017-12-14	STANDARD
LABELING; Labeling	SUPPL	11	AP	2021-03-12	STANDARD
LABELING; Labeling	SUPPL	12	AP	2021-03-12	STANDARD
LABELING; Labeling	SUPPL	14	AP	2022-08-09	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	14	Null	15

TE Codes

001	Prescription	AB1
002	Prescription	AB1
003	Prescription	AB1

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202304
            [companyName] => PRINSTON INC
            [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":"05\/26\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/14\/2017","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/14\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/14\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-12-14
        )

)