ANDA 208953

ZYDUS PHARMS

FDA Drug Application

Application #208953

Documents

• Letter: 2018-12-20

Application Sponsors

ANDA 208953

ZYDUS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SUPPOSITORY;RECTAL

1GM

0

MESALAMINE

MESALAMINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-02-12	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-10-28	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-10-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7
SUPPL	5	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208953
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MESALAMINE","activeIngredients":"MESALAMINE","strength":"1GM","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/12\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208953Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-02-12
        )

)