ANDA 078499

UPSHER SMITH LABS

FDA Drug Application

Application #078499

Application Sponsors

ANDA 078499

UPSHER SMITH LABS

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	2010-01-07
LABELING; Labeling	SUPPL	3	AP	2010-08-17
LABELING; Labeling	SUPPL	4	AP	2011-06-17
LABELING; Labeling	SUPPL	6	AP	2011-06-17
LABELING; Labeling	SUPPL	7	AP	2014-11-19	STANDARD
LABELING; Labeling	SUPPL	8	AP	2014-11-19	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	6	Null	8
SUPPL	7	Null	7
SUPPL	8	Null	7

TE Codes

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

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78499
            [companyName] => UPSHER SMITH LABS
            [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
        )

)