ANDA 200218

ANI PHARMS INC

FDA Drug Application

Application #200218

Application Sponsors

ANDA 200218

ANI PHARMS INC

Marketing Status

• Discontinued: 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

N/A; Not Applicable	ORIG	1	AP	2013-08-30
LABELING; Labeling	SUPPL	3	AP	2015-02-25	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-02-25	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-03-04	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-03-04	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-03-10	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	9	Null	15

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200218
            [companyName] => ANI PHARMS INC
            [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":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/30\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/25\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/25\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-02-25
        )

)