ANDA 208949

ZYDUS PHARMS

FDA Drug Application

Application #208949

Application Sponsors

ANDA 208949

ZYDUS PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	25MG	0	TOPIRAMATE	TOPIRAMATE
002	CAPSULE, EXTENDED RELEASE;ORAL	50MG	0	TOPIRAMATE	TOPIRAMATE
003	CAPSULE, EXTENDED RELEASE;ORAL	100MG	0	TOPIRAMATE	TOPIRAMATE
004	CAPSULE, EXTENDED RELEASE;ORAL	150MG	0	TOPIRAMATE	TOPIRAMATE
005	CAPSULE, EXTENDED RELEASE;ORAL	200MG	0	TOPIRAMATE	TOPIRAMATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-11-28

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB2
002	Prescription	AB2
003	Prescription	AB2
004	Prescription	AB2
005	Prescription	AB2

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208949
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"25MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"50MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"100MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"150MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"200MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TOPIRAMATE","submission":"TOPIRAMATE","actionType":"25MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TOPIRAMATE","submission":"TOPIRAMATE","actionType":"50MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TOPIRAMATE","submission":"TOPIRAMATE","actionType":"100MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TOPIRAMATE","submission":"TOPIRAMATE","actionType":"150MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TOPIRAMATE","submission":"TOPIRAMATE","actionType":"200MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)