ANDA 090705

INVAGEN PHARMS

FDA Drug Application

Application #090705

Application Sponsors

ANDA 090705

INVAGEN PHARMS

Marketing Status

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

Application Products

001	CAPSULE;ORAL	100MG	0	GABAPENTIN	GABAPENTIN
002	CAPSULE;ORAL	300MG	0	GABAPENTIN	GABAPENTIN
003	CAPSULE;ORAL	400MG	0	GABAPENTIN	GABAPENTIN

FDA Submissions

	ORIG	1	AP	2009-12-30
LABELING; Labeling	SUPPL	3	AP	2011-12-15
LABELING; Labeling	SUPPL	4	AP	2012-04-11
LABELING; Labeling	SUPPL	8	AP	2014-10-30	STANDARD
LABELING; Labeling	SUPPL	9	AP	2016-02-03	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-02-03	STANDARD
LABELING; Labeling	SUPPL	12	AP	2016-02-03	STANDARD
LABELING; Labeling	SUPPL	17	AP	2020-09-08	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-09-08	STANDARD
LABELING; Labeling	SUPPL	27	AP	2020-09-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	8
SUPPL	4	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	17	Null	15
SUPPL	18	Null	7
SUPPL	27	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90705
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"400MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"400MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)