ANDA 211519

ZYDUS PHARMS

FDA Drug Application

Application #211519

Documents

• Letter: 2020-05-15

Application Sponsors

ANDA 211519

ZYDUS PHARMS

Marketing Status

• Discontinued: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	0.6MG	0	COLCHICINE	COLCHICINE
002	TABLET;ORAL	0.3MG	0	COLCHICINE	COLCHICINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-02-19	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-09-15	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211519
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLCHICINE","activeIngredients":"COLCHICINE","strength":"0.6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"COLCHICINE","activeIngredients":"COLCHICINE","strength":"0.3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/15\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/14\/2019","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)-New Strength","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211519Orig1s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-15
        )

)