ANDA 211603

AUROBINDO PHARMA LTD

FDA Drug Application

Application #211603

Application Sponsors

ANDA 211603

AUROBINDO PHARMA LTD

Marketing Status

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

Application Products

001	CAPSULE;ORAL	EQ 10MG BASE	0	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 25MG BASE	0	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE
003	CAPSULE;ORAL	EQ 50MG BASE	0	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE
004	CAPSULE;ORAL	EQ 75MG BASE	0	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE
005	CAPSULE;ORAL	EQ 100MG BASE	0	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-03-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

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

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211603
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXEPIN HYDROCHLORIDE","activeIngredients":"DOXEPIN HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXEPIN HYDROCHLORIDE","activeIngredients":"DOXEPIN HYDROCHLORIDE","strength":"EQ 25MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXEPIN HYDROCHLORIDE","activeIngredients":"DOXEPIN HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXEPIN HYDROCHLORIDE","activeIngredients":"DOXEPIN HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXEPIN HYDROCHLORIDE","activeIngredients":"DOXEPIN HYDROCHLORIDE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/27\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-27
        )

)