ANDA 206122

SCIEGEN PHARMS INC

FDA Drug Application

Application #206122

Documents

• Letter: 2016-10-06
• REMS: 2017-10-12

Application Sponsors

ANDA 206122

SCIEGEN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

150MG

0

BUPROPION HYDROCHLORIDE

BUPROPION HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-08-17	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-12-13	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-12-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2021-12-13	UNKNOWN

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15
SUPPL	5	Null	7
SUPPL	7	Null	7

TE Codes

001

Prescription

AB2

CDER Filings

SCIEGEN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206122
            [companyName] => SCIEGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/17\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206122Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/30\/2017","submission":"SUPPL-1","supplementCategories":"REMS - MODIFIED - D-N-A, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-06-30
        )

)