ANDA 078235

ZYDUS PHARMS USA INC

FDA Drug Application

Application #078235

Documents

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

Application Sponsors

ANDA 078235

ZYDUS PHARMS USA INC

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
REMS; REMS	SUPPL	2	AP	2010-01-13
LABELING; Labeling	SUPPL	4	AP	2010-08-13
LABELING; Labeling	SUPPL	6	AP	2011-06-24
LABELING; Labeling	SUPPL	7	AP	2011-06-24
LABELING; Labeling	SUPPL	8	AP	2014-11-18
LABELING; Labeling	SUPPL	10	AP	2014-11-18	STANDARD
LABELING; Labeling	SUPPL	12	AP	2014-11-18	STANDARD
LABELING; Labeling	SUPPL	14	AP	2014-11-18	STANDARD
LABELING; Labeling	SUPPL	15	AP	2015-10-30	STANDARD
LABELING; Labeling	SUPPL	16	AP	2015-10-30	STANDARD
LABELING; Labeling	SUPPL	18	AP	2015-10-30	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-10-01	STANDARD
LABELING; Labeling	SUPPL	21	AP	2020-10-01	STANDARD
LABELING; Labeling	SUPPL	23	AP	2020-10-01	STANDARD
LABELING; Labeling	SUPPL	24	AP	2020-10-01	STANDARD
LABELING; Labeling	SUPPL	25	AP	2020-10-01	STANDARD
LABELING; Labeling	SUPPL	29	AP	2020-10-01	STANDARD
LABELING; Labeling	SUPPL	31	AP	2022-01-07	STANDARD

Submissions Property Types

SUPPL	1	Null	7
SUPPL	2	Null	7
SUPPL	4	Null	7
SUPPL	8	Null	7
SUPPL	10	Null	15
SUPPL	12	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	15
SUPPL	16	Null	7
SUPPL	18	Null	15
SUPPL	20	Null	15
SUPPL	21	Null	15
SUPPL	23	Null	15
SUPPL	24	Null	7
SUPPL	25	Null	7
SUPPL	29	Null	7
SUPPL	31	Null	15

TE Codes

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

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78235
            [companyName] => ZYDUS PHARMS USA INC
            [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
        )

)