ANDA 078926

ZYDUS PHARMS USA INC

FDA Drug Application

Application #078926

Application Sponsors

ANDA 078926

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	600MG	0	GABAPENTIN	GABAPENTIN
002	TABLET;ORAL	800MG	0	GABAPENTIN	GABAPENTIN

FDA Submissions

	ORIG	1	AP	2011-02-11
LABELING; Labeling	SUPPL	2	AP	2012-04-11
LABELING; Labeling	SUPPL	5	AP	2014-11-08	STANDARD
LABELING; Labeling	SUPPL	7	AP	2014-11-08	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-10-28	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-10-28	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-10-28	STANDARD
LABELING; Labeling	SUPPL	15	AP	2020-10-28	STANDARD
LABELING; Labeling	SUPPL	17	AP	2020-10-28	STANDARD
LABELING; Labeling	SUPPL	18	AP	2021-09-09	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	5	Null	15
SUPPL	7	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	12	Null	15
SUPPL	15	Null	7
SUPPL	17	Null	7
SUPPL	18	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78926
            [companyName] => ZYDUS PHARMS USA INC
            [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
        )

)