ANDA 090162

UNICHEM LABS LTD

FDA Drug Application

Application #090162

Documents

• Other Important Information from FDA: 2009-04-14

Application Sponsors

ANDA 090162

UNICHEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	25MG	0	TOPIRAMATE	TOPIRAMATE
002	TABLET;ORAL	50MG	0	TOPIRAMATE	TOPIRAMATE
003	TABLET;ORAL	100MG	0	TOPIRAMATE	TOPIRAMATE
004	TABLET;ORAL	200MG	0	TOPIRAMATE	TOPIRAMATE

FDA Submissions

	ORIG	1	AP	2009-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2013-02-19
LABELING; Labeling	SUPPL	5	AP	2014-12-01	STANDARD

Submissions Property Types

SUPPL	1	Null	7
SUPPL	2	Null	0
SUPPL	5	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

UNICHEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90162
            [companyName] => UNICHEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TOPIRAMATE","submission":"TOPIRAMATE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TOPIRAMATE","submission":"TOPIRAMATE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TOPIRAMATE","submission":"TOPIRAMATE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TOPIRAMATE","submission":"TOPIRAMATE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)