ANDA 075067

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #075067

Documents

• Letter: 1999-07-19
• Review: 1999-07-19

Application Sponsors

ANDA 075067

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INHALATION

10MG/ML

0

CROMOLYN SODIUM

CROMOLYN SODIUM

FDA Submissions

	ORIG	1	AP	1999-07-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-02-20
LABELING; Labeling	SUPPL	6	AP	2005-01-06

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75067
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CROMOLYN SODIUM","activeIngredients":"CROMOLYN SODIUM","strength":"10MG\/ML","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CROMOLYN SODIUM","submission":"CROMOLYN SODIUM","actionType":"10MG\/ML","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)