NDA 016968

ALCON

FDA Drug Application

Application #016968

Documents

• Letter: 2002-11-25
• Letter: 2004-11-16
• Label: 2002-11-25
• Label: 2016-01-26
• Letter: 2016-01-22
• Label: 2004-11-16

Application Sponsors

NDA 016968

ALCON

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAOCULAR

0.01%

1

MIOSTAT

CARBACHOL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1972-09-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1978-08-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1978-06-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1978-06-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1980-04-24	PRIORITY
LABELING; Labeling	SUPPL	6	AP	1980-04-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1983-05-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1983-12-06	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1984-08-13
LABELING; Labeling	SUPPL	12	AP	1989-12-14
EFFICACY; Efficacy	SUPPL	13	AP	1995-08-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1996-06-26	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1997-01-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1997-05-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1999-04-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1999-10-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-12-18	PRIORITY
LABELING; Labeling	SUPPL	20	AP	2002-11-25	STANDARD
LABELING; Labeling	SUPPL	22	AP	2004-11-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2015-02-23	PRIORITY
LABELING; Labeling	SUPPL	29	AP	2016-01-21	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	15

CDER Filings

ALCON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16968
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIOSTAT","activeIngredients":"CARBACHOL","strength":"0.01%","dosageForm":"SOLUTION;INTRAOCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/21\/2016","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/016968s029lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2004","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/16968s022lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2002","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/16968slr020_Miostat_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MIOSTAT","submission":"CARBACHOL","actionType":"0.01%","submissionClassification":"SOLUTION;INTRAOCULAR","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-01-21
        )

)