ANDA 040075

BAUSCH AND LOMB

FDA Drug Application

Application #040075

Application Sponsors

ANDA 040075

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

1%

0

PENTOLAIR

CYCLOPENTOLATE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1994-04-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-05-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-02-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-11-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-05-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-04-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-10-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-03-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-11-27
LABELING; Labeling	SUPPL	25	AP	2021-02-12	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	11	Null	0
SUPPL	12	Null	0
SUPPL	25	Null	7

TE Codes

001

Prescription

AT

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40075
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENTOLAIR","activeIngredients":"CYCLOPENTOLATE HYDROCHLORIDE","strength":"1%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PENTOLAIR","submission":"CYCLOPENTOLATE HYDROCHLORIDE","actionType":"1%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)