NDA 209376

AMERICAN REGENT INC

FDA Drug Application

Application #209376

Documents

• Label: 2020-07-06
• Letter: 2020-07-07
• Review: 2021-02-22
• Label: 2021-07-07

Application Sponsors

NDA 209376

AMERICAN REGENT INC

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	1ML	2	TRALEMENT	TRACE ELEMENTS
002	SOLUTION;INTRAVENOUS	(5ML) EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG BASE/ML;EQ 3MG BASE/ML	1	TRALEMENT	CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE
003	SOLUTION;INTRAVENOUS	(1ML) EQ 0.06MG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG BASE/ML;EQ 1MG BASE/ML	1	TRALEMENT	CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2020-07-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2021-06-30	STANDARD

Submissions Property Types

ORIG

1

Null

40

TE Codes

001

Prescription

TBD

CDER Filings

AMERICAN REGENT INC

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(
    [0] => Array
        (
            [ApplNo] => 209376
            [companyName] => AMERICAN REGENT INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRALEMENT","activeIngredients":"TRACE ELEMENTS","strength":"1ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"07\/02\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209376s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/02\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209376s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209376Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-07-02
        )

)