ANDA 208363

PURACAP PHARM LLC

FDA Drug Application

Application #208363

Documents

• Review: 2019-02-15

Application Sponsors

ANDA 208363

PURACAP PHARM LLC

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

EQ 200MG BASE

0

NAPROXEN SODIUM

NAPROXEN SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-03-15	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-12-13	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

CDER Filings

PURACAP PHARM LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208363
            [companyName] => PURACAP PHARM LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 200MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/15\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/208363Orig1s000ApprovRoutingSummary.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/13\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-13
        )

)