ANDA 206318

ZYDUS NOVELTECH INC

FDA Drug Application

Application #206318

Application Sponsors

ANDA 206318

ZYDUS NOVELTECH INC

Marketing Status

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

Application Products

001	FILM, EXTENDED RELEASE;TRANSDERMAL	4.6MG/24HR	0	RIVASTIGMINE	RIVASTIGMINE
002	FILM, EXTENDED RELEASE;TRANSDERMAL	9.5MG/24HR	0	RIVASTIGMINE	RIVASTIGMINE
003	FILM, EXTENDED RELEASE;TRANSDERMAL	13.3MG/24HR	0	RIVASTIGMINE	RIVASTIGMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-03-04

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206318
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIVASTIGMINE","activeIngredients":"RIVASTIGMINE","strength":"4.6MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RIVASTIGMINE","activeIngredients":"RIVASTIGMINE","strength":"9.5MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RIVASTIGMINE","activeIngredients":"RIVASTIGMINE","strength":"13.3MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-04
        )

)