NDA 209377

AM REGENT

FDA Drug Application

Application #209377

Documents

• Label: 2019-07-19
• Letter: 2019-07-19
• Review: 2019-09-30
• Pediatric Other: 1900-01-01
• Pediatric Other: 1900-01-01
• Label: 2020-10-30
• Letter: 2020-11-02

Application Sponsors

NDA 209377

AM REGENT

Marketing Status

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

Application Products

001	SOLUTION;INTRAVENOUS	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	1	ZINC SULFATE	ZINC SULFATE
002	SOLUTION;INTRAVENOUS	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	1	ZINC SULFATE	ZINC SULFATE
003	SOLUTION;INTRAVENOUS	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	0	ZINC SULFATE	ZINC SULFATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2019-07-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-10-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209377
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZINC SULFATE","activeIngredients":"ZINC SULFATE","strength":"EQ 30MG BASE\/10ML (EQ 3MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ZINC SULFATE","activeIngredients":"ZINC SULFATE","strength":"EQ 25MG BASE\/5ML (EQ 5MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ZINC SULFATE","activeIngredients":"ZINC SULFATE","strength":"EQ 10MG BASE\/10ML (EQ 1MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/28\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209377s003lbl.pdf\"}]","notes":""},{"actionDate":"07\/18\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209377s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/18\/2019","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\\\/2019\\\/209377s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209377Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/209377Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/28\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209377s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209377Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-10-28
        )

)