ANDA 213203

AUROBINDO PHARMA LTD

FDA Drug Application

Application #213203

Application Sponsors

ANDA 213203

AUROBINDO PHARMA LTD

Marketing Status

• Over-the-counter: 001
• Over-the-counter: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	600MG;60MG	0	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	1.2GM;120MG	0	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-03-25

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213203
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE","activeIngredients":"GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"600MG;60MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE","activeIngredients":"GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"1.2GM;120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/25\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-25
        )

)