Application Sponsors
ANDA 200218 | ANI PHARMS INC | |
Marketing Status
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
)
)