ANDA 201068

MYLAN PHARMS INC

FDA Drug Application

Application #201068

Application Sponsors

ANDA 201068

MYLAN PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	UNKNOWN	UNKNOWN	0	SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE
002	TABLET;ORAL	800MG	0	SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2020-12-15

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201068
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEVELAMER HYDROCHLORIDE","activeIngredients":"SEVELAMER HYDROCHLORIDE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SEVELAMER HYDROCHLORIDE","activeIngredients":"SEVELAMER HYDROCHLORIDE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/15\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-15
        )

)