ANDA 208518

PAR PHARM INC

FDA Drug Application

Application #208518

Documents

• Letter: 2018-01-08

Application Sponsors

ANDA 208518

PAR PHARM INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

10MG;10MG

0

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-12-06

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208518
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE","activeIngredients":"DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE","strength":"10MG;10MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208518Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/24\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-24
        )

)