ANDA 211820

UNICHEM LABS LTD

FDA Drug Application

Application #211820

Application Sponsors

ANDA 211820

UNICHEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	100MG	0	ALLOPURINOL	ALLOPURINOL
002	TABLET;ORAL	300MG	0	ALLOPURINOL	ALLOPURINOL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-03-12	STANDARD
LABELING; Labeling	SUPPL	6	AP	2023-01-12	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

UNICHEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211820
            [companyName] => UNICHEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALLOPURINOL","activeIngredients":"ALLOPURINOL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALLOPURINOL","activeIngredients":"ALLOPURINOL","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/12\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-12
        )

)