ANDA 040675

HI TECH

FDA Drug Application

Application #040675

Application Sponsors

ANDA 040675

HI TECH

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

5MG/5ML;6.25MG/5ML

0

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2014-12-23

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

HI TECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40675
            [companyName] => HI TECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE","strength":"5MG\/5ML;6.25MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE","submission":"PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE","actionType":"5MG\/5ML;6.25MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)