ANDA 040560

NOSTRUM LABS INC

FDA Drug Application

Application #040560

Application Sponsors

ANDA 040560

NOSTRUM LABS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, EXTENDED RELEASE; ORAL	600MG	0	THEOPHYLLINE	THEOPHYLLINE
002	TABLET, EXTENDED RELEASE;ORAL	600MG	0	THEOPHYLLINE	THEOPHYLLINE
003	TABLET, EXTENDED RELEASE;ORAL	400MG	0	THEOPHYLLINE	THEOPHYLLINE

FDA Submissions

	ORIG	1	AP	2006-04-21
LABELING; Labeling	SUPPL	6	AP	2015-11-20	STANDARD

Submissions Property Types

SUPPL

6

Null

15

TE Codes

002	Prescription	AB
003	Prescription	AB

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40560
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"THEOPHYLLINE","activeIngredients":"THEOPHYLLINE","strength":"600MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"THEOPHYLLINE","activeIngredients":"THEOPHYLLINE","strength":"600MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"THEOPHYLLINE","activeIngredients":"THEOPHYLLINE","strength":"400MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THEOPHYLLINE","submission":"THEOPHYLLINE","actionType":"600MG","submissionClassification":"TABLET, EXTENDED RELEASE; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"THEOPHYLLINE","submission":"THEOPHYLLINE","actionType":"600MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"THEOPHYLLINE","submission":"THEOPHYLLINE","actionType":"400MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)