NDA 201849

FRESENIUS KABI USA

FDA Drug Application

Application #201849

Documents

• Letter: 2015-12-02
• Label: 2015-12-02
• Review: 2016-05-25
• Letter: 2015-05-13
• Letter: 2019-09-11
• Label: 2019-09-11
• Letter: 2021-08-02
• Label: 2021-08-02
• Letter: 2022-07-15
• Label: 2022-07-15

Application Sponsors

NDA 201849

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAMUSCULAR, INTRAVENOUS

EQ 1MG BASE/VIAL

1

GLUCAGON

GLUCAGON HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2015-05-08	STANDARD
LABELING; Labeling	SUPPL	2	AP	2015-12-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2015-11-03	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2019-09-09	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-07-29	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-07-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	0
SUPPL	5	Null	15
SUPPL	9	Null	15
SUPPL	13	Null	7

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201849
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLUCAGON","activeIngredients":"GLUCAGON HYDROCHLORIDE","strength":"EQ 1MG BASE\/VIAL","dosageForm":"POWDER;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/09\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201849s005lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/201849s002lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/08\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/201849Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/201849Orig1s000TOC.cfm\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/09\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201849s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/201849Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"11\/03\/2015","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/01\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/201849s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/201849Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"11\/03\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-09
        )

)