ANDA 202510

PAR PHARM

FDA Drug Application

Application #202510

Application Sponsors

ANDA 202510

PAR PHARM

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	TABLET; ORAL	3MG	0	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE
002	TABLET; ORAL	6MG	0	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2012-06-28

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

STRIDES ARCOLAB LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202510
            [companyName] => STRIDES ARCOLAB LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXEPIN HYDROCHLORIDE","activeIngredients":"DOXEPIN HYDROCHLORIDE","strength":"EQ 3MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DOXEPIN HYDROCHLORIDE","activeIngredients":"DOXEPIN HYDROCHLORIDE","strength":"EQ 6MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-24
        )

)