ANDA 210971

NOVITIUM PHARMA

FDA Drug Application

Application #210971

Application Sponsors

ANDA 210971

NOVITIUM PHARMA

Marketing Status

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

Application Products

001	CAPSULE;ORAL	EQ 1MG BASE	0	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 2MG BASE	0	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE
003	CAPSULE;ORAL	EQ 5MG BASE	0	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-10-03

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210971
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRAZOSIN HYDROCHLORIDE","activeIngredients":"PRAZOSIN HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAZOSIN HYDROCHLORIDE","activeIngredients":"PRAZOSIN HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAZOSIN HYDROCHLORIDE","activeIngredients":"PRAZOSIN HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/03\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-03
        )

)