ANDA 202179

MYLAN PHARMS INC

FDA Drug Application

Application #202179

Application Sponsors

ANDA 202179

MYLAN PHARMS INC

Marketing Status

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

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 10MG BASE	0	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE
002	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 15MG BASE	0	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE
003	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 30MG BASE	0	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2013-04-10

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202179
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREDNISOLONE SODIUM PHOSPHATE","activeIngredients":"PREDNISOLONE SODIUM PHOSPHATE","strength":"EQ 10MG BASE","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREDNISOLONE SODIUM PHOSPHATE","activeIngredients":"PREDNISOLONE SODIUM PHOSPHATE","strength":"EQ 15MG BASE","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREDNISOLONE SODIUM PHOSPHATE","activeIngredients":"PREDNISOLONE SODIUM PHOSPHATE","strength":"EQ 30MG BASE","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/10\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-04-10
        )

)