ANDA 078428

AMNEAL PHARMS NY

FDA Drug Application

Application #078428

Application Sponsors

ANDA 078428

AMNEAL PHARMS NY

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	2007-07-25
LABELING; Labeling	SUPPL	4	AP	2010-05-17
LABELING; Labeling	SUPPL	7	AP	2010-05-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2012-04-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2011-12-16
LABELING; Labeling	SUPPL	15	AP	2011-03-30
LABELING; Labeling	SUPPL	17	AP	2012-04-19
LABELING; Labeling	SUPPL	22	AP	2014-04-23	STANDARD
LABELING; Labeling	SUPPL	24	AP	2016-11-08	STANDARD
LABELING; Labeling	SUPPL	25	AP	2016-11-08	STANDARD
LABELING; Labeling	SUPPL	26	AP	2016-11-08	STANDARD
LABELING; Labeling	SUPPL	27	AP	2016-11-08	STANDARD
LABELING; Labeling	SUPPL	28	AP	2016-11-08	STANDARD
LABELING; Labeling	SUPPL	29	AP	2016-11-08	STANDARD
LABELING; Labeling	SUPPL	31	AP	2016-11-08	STANDARD
LABELING; Labeling	SUPPL	33	AP	2020-08-21	STANDARD
LABELING; Labeling	SUPPL	36	AP	2020-08-21	STANDARD
LABELING; Labeling	SUPPL	43	AP	2020-08-21	STANDARD

Submissions Property Types

SUPPL	4	Null	7
SUPPL	7	Null	7
SUPPL	9	Null	15
SUPPL	14	Null	7
SUPPL	17	Null	15
SUPPL	22	Null	15
SUPPL	24	Null	15
SUPPL	25	Null	7
SUPPL	26	Null	7
SUPPL	27	Null	7
SUPPL	28	Null	15
SUPPL	29	Null	15
SUPPL	31	Null	31
SUPPL	33	Null	15
SUPPL	36	Null	7
SUPPL	43	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78428
            [companyName] => AMNEAL PHARMS NY
            [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
        )

)