ANDA 204963

NOVAST LABS

FDA Drug Application

Application #204963

Application Sponsors

ANDA 204963

NOVAST LABS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	TABLET;ORAL	10MG	0	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE
002	TABLET;ORAL	25MG	0	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE
003	TABLET;ORAL	50MG	0	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE
004	TABLET;ORAL	75MG	0	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE
005	TABLET;ORAL	100MG	0	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE
006	TABLET;ORAL	150MG	0	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-12-26	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-09-30	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204963
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESIPRAMINE HYDROCHLORIDE","activeIngredients":"DESIPRAMINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DESIPRAMINE HYDROCHLORIDE","activeIngredients":"DESIPRAMINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DESIPRAMINE HYDROCHLORIDE","activeIngredients":"DESIPRAMINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DESIPRAMINE HYDROCHLORIDE","activeIngredients":"DESIPRAMINE HYDROCHLORIDE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DESIPRAMINE HYDROCHLORIDE","activeIngredients":"DESIPRAMINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DESIPRAMINE HYDROCHLORIDE","activeIngredients":"DESIPRAMINE HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/30\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-30
        )

)