ANDA 074118

NOSTRUM LABS INC

FDA Drug Application

Application #074118

Application Sponsors

ANDA 074118

NOSTRUM LABS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

	ORIG	1	AP	1993-06-15
LABELING; Labeling	SUPPL	3	AP	2011-10-21
LABELING; Labeling	SUPPL	4	AP	2011-09-14
LABELING; Labeling	SUPPL	5	AP	2015-06-30	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-06-30	STANDARD
LABELING; Labeling	SUPPL	9	AP	2015-06-30	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-12-23	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-12-23	STANDARD

Submissions Property Types

SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	12	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74118
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIROXICAM","activeIngredients":"PIROXICAM","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIROXICAM","activeIngredients":"PIROXICAM","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PIROXICAM","submission":"PIROXICAM","actionType":"20MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PIROXICAM","submission":"PIROXICAM","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)