ANDA 078877

ZYDUS PHARMS USA INC

FDA Drug Application

Application #078877

Application Sponsors

ANDA 078877

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	15MG	0	TOPIRAMATE	TOPIRAMATE
002	CAPSULE;ORAL	25MG	0	TOPIRAMATE	TOPIRAMATE

FDA Submissions

	ORIG	1	AP	2009-10-14
LABELING; Labeling	SUPPL	2	AP	2011-06-24
LABELING; Labeling	SUPPL	3	AP	2014-11-18
LABELING; Labeling	SUPPL	5	AP	2014-11-18	STANDARD
LABELING; Labeling	SUPPL	7	AP	2014-11-18	STANDARD
LABELING; Labeling	SUPPL	8	AP	2014-11-18	STANDARD
LABELING; Labeling	SUPPL	9	AP	2015-10-30	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-10-30	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-10-30	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-10-01	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-10-01	STANDARD
LABELING; Labeling	SUPPL	15	AP	2020-10-01	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-10-01	STANDARD
LABELING; Labeling	SUPPL	17	AP	2020-10-01	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-10-01	STANDARD
LABELING; Labeling	SUPPL	21	AP	2022-01-07	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	5	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	15	Null	7
SUPPL	16	Null	7
SUPPL	17	Null	15
SUPPL	20	Null	7
SUPPL	21	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78877
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TOPIRAMATE","submission":"TOPIRAMATE","actionType":"15MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TOPIRAMATE","submission":"TOPIRAMATE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)