ANDA 209921

ANI PHARMS INC

FDA Drug Application

Application #209921

Documents

• Letter: 2019-06-17

Application Sponsors

ANDA 209921

ANI PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

250MG

0

PENICILLAMINE

PENICILLAMINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-05-07	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-08-27	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209921
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENICILLAMINE","activeIngredients":"PENICILLAMINE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/07\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209921Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-07
        )

)