ANDA 076830

ALVOGEN

FDA Drug Application

Application #076830

Application Sponsors

ANDA 076830

ALVOGEN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.3%

0

OFLOXACIN

OFLOXACIN

FDA Submissions

	ORIG	1	AP	2004-08-31
LABELING; Labeling	SUPPL	5	AP	2009-02-13
LABELING; Labeling	SUPPL	8	AP	2020-07-15	STANDARD

Submissions Property Types

SUPPL

8

Null

15

TE Codes

001

Prescription

AT

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76830
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"OFLOXACIN","activeIngredients":"OFLOXACIN","strength":"0.3%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OFLOXACIN","submission":"OFLOXACIN","actionType":"0.3%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)