ANDA 207568

AM REGENT

FDA Drug Application

Application #207568

Documents

• Letter: 2018-08-20
• Review: 2020-03-24

Application Sponsors

ANDA 207568

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

0

EPINEPHRINE

EPINEPHRINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-07-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2022-07-14	UNKNOWN

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207568
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPINEPHRINE","activeIngredients":"EPINEPHRINE","strength":"EQ 1MG BASE\/ML (EQ 1MG BASE\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/06\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207568Orig1s000ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2022\\\/207568Orig1_Approval_Pkg.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-06
        )

)