ANDA 075693

RITEDOSE CORP

FDA Drug Application

Application #075693

Documents

• Letter: 2001-01-26

Application Sponsors

ANDA 075693

RITEDOSE CORP

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION

0.02%

0

IPRATROPIUM BROMIDE

IPRATROPIUM BROMIDE

FDA Submissions

	ORIG	1	AP	2001-01-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-04-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-05-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-12-17
LABELING; Labeling	SUPPL	15	AP	2011-10-21
LABELING; Labeling	SUPPL	21	AP	2013-05-20	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	15	Null	15
SUPPL	21	Null	15

TE Codes

001

Prescription

AN

CDER Filings

RITEDOSE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75693
            [companyName] => RITEDOSE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"IPRATROPIUM BROMIDE","activeIngredients":"IPRATROPIUM BROMIDE","strength":"0.02%","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IPRATROPIUM BROMIDE","submission":"IPRATROPIUM BROMIDE","actionType":"0.02%","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)