ANDA 208295

WATSON LABS TEVA

FDA Drug Application

Application #208295

Documents

• Letter: 2020-03-18

Application Sponsors

ANDA 208295

WATSON LABS TEVA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

12MG

0

ALVIMOPAN

ALVIMOPAN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-12-19	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-10-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208295
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALVIMOPAN","activeIngredients":"ALVIMOPAN","strength":"12MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208295Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/08\/2021","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-10-08
        )

)