ANDA 077242

SUN PHARM INDS LTD

FDA Drug Application

Application #077242

Application Sponsors

ANDA 077242

SUN PHARM INDS LTD

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	2006-08-24
LABELING; Labeling	SUPPL	7	AP	2010-05-13
LABELING; Labeling	SUPPL	9	AP	2011-03-30
REMS; REMS	SUPPL	10	AP	2011-03-30
LABELING; Labeling	SUPPL	12	AP	2014-12-12	STANDARD
LABELING; Labeling	SUPPL	16	AP	2014-12-12	STANDARD
LABELING; Labeling	SUPPL	18	AP	2015-09-10	STANDARD
LABELING; Labeling	SUPPL	19	AP	2020-08-07	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-08-07	STANDARD
LABELING; Labeling	SUPPL	21	AP	2020-08-07	STANDARD
LABELING; Labeling	SUPPL	27	AP	2020-10-27	STANDARD

Submissions Property Types

SUPPL	7	Null	7
SUPPL	12	Null	15
SUPPL	16	Null	7
SUPPL	18	Null	15
SUPPL	19	Null	7
SUPPL	20	Null	7
SUPPL	21	Null	7
SUPPL	27	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77242
            [companyName] => SUN PHARM INDS LTD
            [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
        )

)