ANDA 075928

RUBICON

FDA Drug Application

Application #075928

Documents

• Letter: 2004-06-10
• Letter: 2003-04-10

Application Sponsors

ANDA 075928

RUBICON

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.3% BASE

0

CIPROFLOXACIN HYDROCHLORIDE

CIPROFLOXACIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2004-06-09
LABELING; Labeling	SUPPL	6	AP	2005-04-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2011-05-25

Submissions Property Types

SUPPL

15

Null

7

CDER Filings

RUBICON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75928
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIPROFLOXACIN HYDROCHLORIDE","activeIngredients":"CIPROFLOXACIN HYDROCHLORIDE","strength":"EQ 0.3% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CIPROFLOXACIN HYDROCHLORIDE","submission":"CIPROFLOXACIN HYDROCHLORIDE","actionType":"EQ 0.3% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)