ANDA 078734

SUN PHARM INDS LTD

FDA Drug Application

Application #078734

Documents

• Letter: 2009-06-30
• Review: 2011-12-16

Application Sponsors

ANDA 078734

SUN PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

300MG/5ML

0

OXCARBAZEPINE

OXCARBAZEPINE

FDA Submissions

	ORIG	1	AP	2009-06-26
LABELING; Labeling	SUPPL	3	AP	2015-02-04
LABELING; Labeling	SUPPL	6	AP	2013-04-12	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-02-04	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-02-04	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-11-05	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-11-05	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	3	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	15

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78734
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"300MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXCARBAZEPINE","submission":"OXCARBAZEPINE","actionType":"300MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)