ANDA 203088

BRECKENRIDGE

FDA Drug Application

Application #203088

Documents

• Letter: 2018-05-24

Application Sponsors

ANDA 203088

BRECKENRIDGE

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	2014-06-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2015-12-22	UNKNOWN
UNKNOWN;	SUPPL	7	AP	2018-05-23	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

TE Codes

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

CDER Filings

BRECKENRIDGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203088
            [companyName] => BRECKENRIDGE
            [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":"06\/11\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203088Orig1s007ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/23\/2018","submission":"SUPPL-7","supplementCategories":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/22\/2015","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-05-23
        )

)