ANDA 040086

RHODES PHARMS

FDA Drug Application

Application #040086

Application Sponsors

ANDA 040086

RHODES PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

	ORIG	1	AP	1996-04-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-08-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-08-28
LABELING; Labeling	SUPPL	7	AP	2002-12-19
LABELING; Labeling	SUPPL	8	AP	2003-11-20
LABELING; Labeling	SUPPL	17	AP	2011-10-14

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	17	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

RHODES PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40086
            [companyName] => RHODES PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"THEOPHYLLINE","activeIngredients":"THEOPHYLLINE","strength":"600MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"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":"400MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)