ANDA 206005

XELLIA PHARMS APS

FDA Drug Application

Application #206005

Application Sponsors

ANDA 206005

XELLIA PHARMS APS

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

500MG/VIAL

0

DAPTOMYCIN

DAPTOMYCIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-06-15	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-10-03	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-10-03	STANDARD
LABELING; Labeling	SUPPL	14	AP	2019-10-03	STANDARD
LABELING; Labeling	SUPPL	17	AP	2020-09-09	STANDARD
LABELING; Labeling	SUPPL	19	AP	2020-09-09	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	7
SUPPL	11	Null	7
SUPPL	14	Null	15
SUPPL	17	Null	7
SUPPL	19	Null	7

TE Codes

001

Prescription

AP

CDER Filings

XELLIA PHARMS APS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206005
            [companyName] => XELLIA PHARMS APS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"500MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/15\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/09\/2020","submission":"SUPPL-19","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/09\/2020","submission":"SUPPL-17","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/03\/2019","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/03\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/03\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/21\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-09
        )

)