ANDA 075111

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #075111

Documents

• Letter: 1999-04-23
• Label: 1999-04-23
• Review: 1999-04-23

Application Sponsors

ANDA 075111

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INHALATION

0.02%

0

IPRATROPIUM BROMIDE

IPRATROPIUM BROMIDE

FDA Submissions

	ORIG	1	AP	1999-04-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-08-17
LABELING; Labeling	SUPPL	6	AP	2000-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-01-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-05-21

Submissions Property Types

SUPPL	1	Null	0
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	9	Null	0

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75111
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IPRATROPIUM BROMIDE","activeIngredients":"IPRATROPIUM BROMIDE","strength":"0.02%","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/22\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/99\\\/75-111_Ipratropium%20Bromide_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"IPRATROPIUM BROMIDE","submission":"IPRATROPIUM BROMIDE","actionType":"0.02%","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1999-04-22
        )

)