ANDA 202761

ZYDUS PHARMS USA INC

FDA Drug Application

Application #202761

Application Sponsors

ANDA 202761

ZYDUS PHARMS USA INC

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

2013-02-22

Submissions Property Types

ORIG

1

Null

17

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202761
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXEPIN HYDROCHLORIDE","activeIngredients":"DOXEPIN HYDROCHLORIDE","strength":"3MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DOXEPIN HYDROCHLORIDE","activeIngredients":"DOXEPIN HYDROCHLORIDE","strength":"6MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/22\/2013","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-02-22
        )

)