ANDA 203261

ANI PHARMS INC

FDA Drug Application

Application #203261

Application Sponsors

ANDA 203261

ANI PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

25MG

0

CARBIDOPA

CARBIDOPA

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-03-10
LABELING; Labeling	SUPPL	5	AP	2020-04-19	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203261
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBIDOPA","activeIngredients":"CARBIDOPA","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/10\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/19\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-19
        )

)