ANDA 077661

RUBICON

FDA Drug Application

Application #077661

Application Sponsors

ANDA 077661

RUBICON

Marketing Status

• Prescription: 004
• Prescription: 005

Application Products

004	TABLET;ORAL	600MG	0	GABAPENTIN	GABAPENTIN
005	TABLET;ORAL	800MG	0	GABAPENTIN	GABAPENTIN

FDA Submissions

	ORIG	1	AP	2006-09-13
LABELING; Labeling	SUPPL	3	AP	2010-08-03
LABELING; Labeling	SUPPL	4	AP	2011-01-31
LABELING; Labeling	SUPPL	7	AP	2011-08-26
LABELING; Labeling	SUPPL	8	AP	2015-04-17	STANDARD
REMS; REMS	SUPPL	9	AP	2013-04-09
LABELING; Labeling	SUPPL	12	AP	2015-04-17	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-09-17	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-10-21	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-10-21	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-10-21	STANDARD
LABELING; Labeling	SUPPL	19	AP	2020-10-21	STANDARD

Submissions Property Types

SUPPL	3	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	15
SUPPL	14	Null	7
SUPPL	16	Null	15
SUPPL	18	Null	15
SUPPL	19	Null	7

TE Codes

004	Prescription	AB
005	Prescription	AB

CDER Filings

RUBICON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77661
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)