ANDA 074116

NOSTRUM LABS INC

FDA Drug Application

Application #074116

Application Sponsors

ANDA 074116

NOSTRUM LABS INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

10MG

0

PIROXICAM

PIROXICAM

FDA Submissions

	ORIG	1	AP	1993-06-15
LABELING; Labeling	SUPPL	3	AP	2011-10-26
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	7
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	7
SUPPL	12	Null	7

TE Codes

001

Prescription

AB

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74116
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)