ANDA 090807

RUBICON

FDA Drug Application

Application #090807

Application Sponsors

ANDA 090807

RUBICON

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, DELAYED RELEASE;ORAL	EQ 20MG BASE	0	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM
002	TABLET, DELAYED RELEASE;ORAL	EQ 40MG BASE	0	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM

FDA Submissions

	ORIG	1	AP	2012-05-02
LABELING; Labeling	SUPPL	2	AP	2014-12-13	STANDARD
LABELING; Labeling	SUPPL	3	AP	2014-12-13	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-04-08	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-11-13	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-11-13	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-11-13	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-11-13	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-11-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	15
SUPPL	9	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

RUBICON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90807
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 20MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 40MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PANTOPRAZOLE SODIUM","submission":"PANTOPRAZOLE SODIUM","actionType":"EQ 20MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PANTOPRAZOLE SODIUM","submission":"PANTOPRAZOLE SODIUM","actionType":"EQ 40MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)