ANDA 206006

RISING

FDA Drug Application

Application #206006

Application Sponsors

ANDA 206006

RISING

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE; CAPSULE, DELAYED REL PELLETS; TABLET;ORAL

500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG

0

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN

AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-10-07	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-03-04	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-03-04	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-04-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206006
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN","activeIngredients":"AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE","strength":"500MG,N\/A,N\/A;N\/A,500MG,N\/A;N\/A,N\/A,30MG","dosageForm":"CAPSULE; CAPSULE, DELAYED REL PELLETS; TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/07\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-10-07
        )

)