ANDA 213584

TARO PHARMS

FDA Drug Application

Application #213584

Documents

• Letter: 2021-05-05

Application Sponsors

ANDA 213584

TARO PHARMS

Marketing Status

• None (Tentative Approval): 001

Application Products

001

UNKNOWN

UNKNOWN

0

OXYMETAZOLINE HYDROCHLORIDE

OXYMETAZOLINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-04-06

UNKNOWN

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

TARO PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213584
            [companyName] => TARO PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYMETAZOLINE HYDROCHLORIDE","activeIngredients":"OXYMETAZOLINE HYDROCHLORIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/06\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-06
        )

)