ANDA 210027

PAR PHARM INC

FDA Drug Application

Application #210027

Documents

• Letter: 2019-09-27

Application Sponsors

ANDA 210027

PAR PHARM INC

Marketing Status

• Discontinued: 001

Application Products

001

POWDER;ORAL

500MG/PACKET

0

SAPROPTERIN DIHYDROCHLORIDE

SAPROPTERIN DIHYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-08-20	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-09-09	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-07-26	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210027
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SAPROPTERIN DIHYDROCHLORIDE","activeIngredients":"SAPROPTERIN DIHYDROCHLORIDE","strength":"500MG\/PACKET","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210027Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/09\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/09\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-09
        )

)