NDA 018796

ALCON

FDA Drug Application

Application #018796

Documents

• Letter: 2008-04-22
• Label: 2008-06-05

Application Sponsors

NDA 018796

ALCON

Marketing Status

• Discontinued: 001

Application Products

001

GEL;OPHTHALMIC

4%

0

PILOPINE HS

PILOCARPINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1984-10-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-06-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1988-12-13	STANDARD
LABELING; Labeling	SUPPL	5	AP	1991-12-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1991-12-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-04-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1993-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-11-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-10-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-12-10	STANDARD
LABELING; Labeling	SUPPL	14	AP	2008-04-17	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0

CDER Filings

ALCON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18796
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"PILOPINE HS","activeIngredients":"PILOCARPINE HYDROCHLORIDE","strength":"4%","dosageForm":"GEL;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/17\/2008","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/018796s014lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PILOPINE HS","submission":"PILOCARPINE HYDROCHLORIDE","actionType":"4%","submissionClassification":"GEL;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2008-04-17
        )

)