ANDA 205548

DR REDDYS LABS LTD

FDA Drug Application

Application #205548

Documents

• Letter: 2020-09-18

Application Sponsors

ANDA 205548

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION/DROPS;OTIC

0.3%;0.1%

0

CIPROFLOXACIN AND DEXAMETHASONE

CIPROFLOXACIN; DEXAMETHASONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-08-10

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205548
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIPROFLOXACIN AND DEXAMETHASONE","activeIngredients":"CIPROFLOXACIN; DEXAMETHASONE","strength":"0.3%;0.1%","dosageForm":"SUSPENSION\/DROPS;OTIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-10
        )

)