ANDA 088235

CMP PHARMA INC

FDA Drug Application

Application #088235

Application Sponsors

ANDA 088235

CMP PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

50MG/5ML

0

ISONIAZID

ISONIAZID

FDA Submissions

	ORIG	1	AP	1983-11-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1991-03-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1992-12-14
LABELING; Labeling	SUPPL	5	AP	1999-09-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-08-09

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0

CDER Filings

CMP PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88235
            [companyName] => CMP PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISONIAZID","activeIngredients":"ISONIAZID","strength":"50MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISONIAZID","submission":"ISONIAZID","actionType":"50MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)