ANDA 074746

PACIFIC PHARMA

FDA Drug Application

Application #074746

Application Sponsors

ANDA 074746

PACIFIC PHARMA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.25% BASE

0

TIMOLOL MALEATE

TIMOLOL MALEATE

FDA Submissions

	ORIG	1	AP	1997-03-25
LABELING; Labeling	SUPPL	2	AP	2000-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-01-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-07-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-11-15
LABELING; Labeling	SUPPL	8	AP	2003-07-14
LABELING; Labeling	SUPPL	10	AP	2005-04-08
LABELING; Labeling	SUPPL	12	AP	2015-10-06	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-04-03	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	12	Null	31
SUPPL	16	Null	31

TE Codes

001

Prescription

AT

CDER Filings

PACIFIC PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74746
            [companyName] => PACIFIC PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIMOLOL MALEATE","activeIngredients":"TIMOLOL MALEATE","strength":"EQ 0.25% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TIMOLOL MALEATE","submission":"TIMOLOL MALEATE","actionType":"EQ 0.25% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)