NDA 204508

BAXTER HLTHCARE CORP

FDA Drug Application

Application #204508

Documents

• Letter: 2016-07-22
• Label: 2013-10-08
• Letter: 2013-10-04
• Label: 2016-07-21
• Review: 2014-10-07
• Summary Review: 2014-10-07
• Letter: 2021-04-14
• Label: 2021-04-16

Application Sponsors

NDA 204508

BAXTER HLTHCARE CORP

Marketing Status

• Prescription: 001

Application Products

001

EMULSION;INTRAVENOUS

16%(160GM/1000ML);4% (40GM/1000ML)

1

CLINOLIPID 20%

OLIVE OIL; SOYBEAN OIL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2013-10-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2014-08-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2014-11-26	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2016-02-08	PRIORITY
LABELING; Labeling	SUPPL	5	AP	2016-07-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2017-01-09	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-04-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	6
SUPPL	15	Null	7

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204508
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINOLIPID 20%","activeIngredients":"OLIVE OIL; SOYBEAN OIL","strength":"16%(160GM\/1000ML);4% (40GM\/1000ML)","dosageForm":"EMULSION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/20\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204508s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204508s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/03\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204508s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204508Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204508Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204508Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/09\/2017","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/20\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204508s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204508Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"02\/08\/2016","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/26\/2014","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/20\/2014","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/06\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-01-09
        )

)