NDA 209379

AM REGENT

FDA Drug Application

Application #209379

Documents

• Label: 2019-05-01
• Letter: 2019-05-02
• Review: 2019-12-17
• Letter: 2020-10-23
• Label: 2020-10-23
• Label: 2021-01-26

Application Sponsors

NDA 209379

AM REGENT

Marketing Status

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

Application Products

001	SOLUTION;INTRAVENOUS	EQ 600MCG BASE/10ML (EQ 60MCG BASE/ML)	1	SELENIOUS ACID	SELENIOUS ACID
002	SOLUTION;INTRAVENOUS	EQ 60MCG BASE/ML (EQ 60MCG BASE/ML)	1	SELENIOUS ACID	SELENIOUS ACID
003	SOLUTION;INTRAVENOUS	EQ 12MCG BASE/2ML (EQ 6MCG BASE/ML)	1	SELENIOUS ACID	SELENIOUS ACID

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2019-04-30	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2020-10-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2021-01-25	STANDARD

Submissions Property Types

ORIG	1	Null	10
SUPPL	3	Null	6

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209379
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"SELENIOUS ACID","activeIngredients":"SELENIOUS ACID","strength":"EQ 600MCG SELENIUM\/10ML (EQ 60MCG SELENIUM\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"SELENIOUS ACID","activeIngredients":"SELENIOUS ACID","strength":"EQ 60MCG SELENIUM\/ML (EQ 60MCG SELENIUM\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"SELENIOUS ACID","activeIngredients":"SELENIOUS ACID","strength":"EQ 12MCG SELENIUM\/2ML (EQ 6MCG SELENIUM\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/25\/2021","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209379s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209379s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209379s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209379s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209379Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/209379Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/25\/2021","submission":"SUPPL-5","supplementCategories":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209379s005lbl.pdf\"}]","notes":">"},{"actionDate":"10\/21\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209379s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209379Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2021-01-25
        )

)