NDA 020213

BAUSCH AND LOMB

FDA Drug Application

Application #020213

Documents

• Letter: 2006-06-06
• Label: 2006-05-31

Application Sponsors

NDA 020213

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;OPHTHALMIC

20MG/VIAL

1

MIOCHOL-E

ACETYLCHOLINE CHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1993-09-22	STANDARD
LABELING; Labeling	SUPPL	2	AP	1995-08-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-10-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-01-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2006-05-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2016-06-17	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	10	Null	0
SUPPL	14	Null	0

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20213
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIOCHOL-E","activeIngredients":"ACETYLCHOLINE CHLORIDE","strength":"20MG\/VIAL","dosageForm":"FOR SOLUTION;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/30\/2006","submission":"SUPPL-10","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020213s010lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"MIOCHOL-E","submission":"ACETYLCHOLINE CHLORIDE","actionType":"20MG\/VIAL","submissionClassification":"FOR SOLUTION;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2006-05-30
        )

)