ANDA 071267

CONTRACT PHARMACAL

FDA Drug Application

Application #071267

Application Sponsors

ANDA 071267

CONTRACT PHARMACAL

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

400MG

0

IBUPROFEN

IBUPROFEN

FDA Submissions

	ORIG	1	AP	1986-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-05-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-01-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-10-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-07-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-07-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-07-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1987-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1987-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1987-12-18
LABELING; Labeling	SUPPL	11	AP	1988-08-10
LABELING; Labeling	SUPPL	12	AP	1989-01-23
LABELING; Labeling	SUPPL	13	AP	2016-05-09	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	15

TE Codes

001

Prescription

AB

CDER Filings

CONTRACT PHARMACAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71267
            [companyName] => CONTRACT PHARMACAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)