NDA 208171

PHARMACOSMOS AS

FDA Drug Application

Application #208171

Documents

• Label: 2020-01-16
• Letter: 2020-01-17
• Review: 2020-05-07
• Letter: 2020-09-14
• Label: 2020-09-21
• Letter: 2022-08-05
• Label: 2022-08-05

Application Sponsors

NDA 208171

PHARMACOSMOS AS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	SOLUTION;INTRAVENOUS	100MG/ML (100MG/ML)	1	MONOFERRIC	FERRIC DERISOMALTOSE
002	SOLUTION;INTRAVENOUS	500MG/5ML (100MG/ML)	1	MONOFERRIC	FERRIC DERISOMALTOSE
003	SOLUTION;INTRAVENOUS	1GM/10ML (100MG/ML)	1	MONOFERRIC	FERRIC DERISOMALTOSE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2020-01-16	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-08-04	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

CDER Filings

PHARMACOSMOS AS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208171
            [companyName] => PHARMACOSMOS AS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MONOFERRIC","activeIngredients":"FERRIC DERISOMALTOSE","strength":"100MG\/ML (100MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MONOFERRIC","activeIngredients":"FERRIC DERISOMALTOSE","strength":"500MG\/5ML (100MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MONOFERRIC","activeIngredients":"FERRIC DERISOMALTOSE","strength":"1GM\/10ML (100MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/11\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208171s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/16\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208171s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/16\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208171s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208171Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/208171Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/11\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208171s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208171Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-09-11
        )

)