ANDA 209180

RISING

FDA Drug Application

Application #209180

Application Sponsors

ANDA 209180

RISING

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 0.5MG BASE	0	ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE
002	TABLET;ORAL	EQ 1MG BASE	0	ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-01-14	STANDARD
REMS; REMS	SUPPL	4	AP	2021-10-18
REMS; REMS	SUPPL	5	AP	2022-05-05

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209180
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALOSETRON HYDROCHLORIDE","activeIngredients":"ALOSETRON HYDROCHLORIDE","strength":"EQ 0.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALOSETRON HYDROCHLORIDE","activeIngredients":"ALOSETRON HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/14\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/06\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-06
        )

)