ANDA 209215

GUARDIAN DRUG

FDA Drug Application

Application #209215

Documents

• Letter: 2018-07-16

Application Sponsors

ANDA 209215

GUARDIAN DRUG

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	600MG	0	GUAIFENESIN	GUAIFENESIN
002	TABLET, EXTENDED RELEASE;ORAL	1.2GM	0	GUAIFENESIN	GUAIFENESIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-09-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

GUARDIAN DRUG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209215
            [companyName] => GUARDIAN DRUG
            [docInserts] => ["",""]
            [products] => [{"drugName":"GUAIFENESIN","activeIngredients":"GUAIFENESIN","strength":"600MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"GUAIFENESIN","activeIngredients":"GUAIFENESIN","strength":"1.2GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209215Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-09-06
        )

)