ANDA 208340

UNICHEM LABS LTD

FDA Drug Application

Application #208340

Application Sponsors

ANDA 208340

UNICHEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	10MG	0	PIROXICAM	PIROXICAM
002	CAPSULE;ORAL	20MG	0	PIROXICAM	PIROXICAM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-04-13	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-10-17	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

UNICHEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208340
            [companyName] => UNICHEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIROXICAM","activeIngredients":"PIROXICAM","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIROXICAM","activeIngredients":"PIROXICAM","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/13\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/17\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-17
        )

)