ANDA 214934

NEXUS PHARMS

FDA Drug Application

Application #214934

Documents

• Letter: 2022-08-30

Application Sponsors

ANDA 214934

NEXUS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 100MG BASE/VIAL

0

MINOCYCLINE HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-07-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

NEXUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214934
            [companyName] => NEXUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MINOCYCLINE HYDROCHLORIDE","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 100MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/22\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-22
        )

)