ANDA 075360

GRANULES INDIA LTD

FDA Drug Application

Application #075360

Documents

• Review: 2007-07-06

Application Sponsors

ANDA 075360

GRANULES INDIA 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	2005-04-06
LABELING; Labeling	SUPPL	3	AP	2006-12-07
LABELING; Labeling	SUPPL	5	AP	2007-04-25
LABELING; Labeling	SUPPL	7	AP	2010-08-03
LABELING; Labeling	SUPPL	10	AP	2011-08-29
LABELING; Labeling	SUPPL	11	AP	2015-04-17	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-04-17	STANDARD
LABELING; Labeling	SUPPL	17	AP	2015-04-17	STANDARD
LABELING; Labeling	SUPPL	18	AP	2015-09-17	STANDARD
LABELING; Labeling	SUPPL	19	AP	2020-07-28	STANDARD
LABELING; Labeling	SUPPL	22	AP	2020-07-28	STANDARD
LABELING; Labeling	SUPPL	23	AP	2020-07-28	STANDARD
LABELING; Labeling	SUPPL	25	AP	2020-07-28	STANDARD
LABELING; Labeling	SUPPL	28	AP	2021-03-05	STANDARD

Submissions Property Types

SUPPL	7	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	15
SUPPL	13	Null	15
SUPPL	17	Null	15
SUPPL	18	Null	7
SUPPL	19	Null	7
SUPPL	22	Null	15
SUPPL	23	Null	15
SUPPL	25	Null	15
SUPPL	28	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

GRANULES INDIA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75360
            [companyName] => GRANULES INDIA 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
        )

)