ANDA 210654

PURACAP PHARM LLC

FDA Drug Application

Application #210654

Application Sponsors

ANDA 210654

PURACAP PHARM LLC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

250MG

0

ETHOSUXIMIDE

ETHOSUXIMIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-03-16	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-08-16	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

PURACAP PHARM LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210654
            [companyName] => PURACAP PHARM LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETHOSUXIMIDE","activeIngredients":"ETHOSUXIMIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/16\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-16
        )

)