ANDA 209876

DR REDDYS

FDA Drug Application

Application #209876

Application Sponsors

ANDA 209876

DR REDDYS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.6MG

0

COLCHICINE

COLCHICINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-09-06	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-12-04	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209876
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLCHICINE","activeIngredients":"COLCHICINE","strength":"0.6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/06\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/30\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-30
        )

)