ANDA 207449

FRESENIUS KABI USA

FDA Drug Application

Application #207449

Documents

• Letter: 2016-10-31
• Label: 2016-11-04

Application Sponsors

ANDA 207449

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

DEXTROSE 5% IN PLASTIC CONTAINER

DEXTROSE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-10-21	STANDARD
LABELING; Labeling	SUPPL	3	AP	2018-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2020-11-20	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2022-07-20	UNKNOWN

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15
SUPPL	14	Null	15
SUPPL	19	Null	7

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207449
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/21\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207449Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/21\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207449Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207449Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/26\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-06-26
        )

)