ANDA 204403

ALVOGEN

FDA Drug Application

Application #204403

Documents

• Letter: 2015-09-08
• Letter: 2015-07-23
• Review: 2019-05-15

Application Sponsors

ANDA 204403

ALVOGEN

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	2015-08-31
UNKNOWN;	ORIG	2	AP	2015-09-03
LABELING; Labeling	SUPPL	4	AP	2020-12-04	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-12-04	STANDARD

Submissions Property Types

ORIG	1	Null	19
ORIG	2	Null	1
SUPPL	4	Null	15
SUPPL	6	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204403
            [companyName] => ALVOGEN
            [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":"09\/03\/2015","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/31\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204403Orig1s000ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204403Orig1s000TAltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/204403Orig1s000.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/24\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/24\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-02-24
        )

)