ANDA 208706

AJANTA PHARMA LTD

FDA Drug Application

Application #208706

Application Sponsors

ANDA 208706

AJANTA PHARMA LTD

Marketing Status

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

Application Products

001	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 20MG BASE	0	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE
002	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 30MG BASE	0	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE
003	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 60MG BASE	0	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE
004	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 40MG BASE	0	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-01-06	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-07-29	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-07-29	STANDARD
LABELING; Labeling	SUPPL	25	AP	2022-07-29	STANDARD
LABELING; Labeling	SUPPL	29	AP	2022-07-29	STANDARD
LABELING; Labeling	SUPPL	42	AP	2022-07-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	2022-07-26	UNKNOWN
LABELING; Labeling	SUPPL	51	AP	2022-07-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	6	Null	7
SUPPL	25	Null	7
SUPPL	29	Null	7
SUPPL	42	Null	31
SUPPL	49	Null	15
SUPPL	51	Null	15

TE Codes

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

CDER Filings

AJANTA PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208706
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DULOXETINE HYDROCHLORIDE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DULOXETINE HYDROCHLORIDE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 30MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DULOXETINE HYDROCHLORIDE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 60MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DULOXETINE HYDROCHLORIDE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-01-06
        )

)