ANDA 075819

CMP PHARMA INC

FDA Drug Application

Application #075819

Application Sponsors

ANDA 075819

CMP PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

50MG/5ML

0

AMANTADINE HYDROCHLORIDE

AMANTADINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-09-11
LABELING; Labeling	SUPPL	2	AP	2012-02-17

Submissions Property Types

SUPPL	1	Null	8
SUPPL	2	Null	15

TE Codes

001

Prescription

AA

CDER Filings

CMP PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75819
            [companyName] => CMP PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMANTADINE HYDROCHLORIDE","activeIngredients":"AMANTADINE HYDROCHLORIDE","strength":"50MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMANTADINE HYDROCHLORIDE","submission":"AMANTADINE HYDROCHLORIDE","actionType":"50MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)