NDA 212516

SUN PHARMA GLOBAL

FDA Drug Application

Application #212516

Documents

• Label: 2019-07-22
• Letter: 2019-07-22
• Medication Guide: 2019-07-24
• Review: 2020-01-29
• Pediatric Other: 1900-01-01
• Label: 2020-06-25
• Medication Guide: 2020-06-25
• Letter: 2020-06-25
• Label: 2021-07-26
• Medication Guide: 2021-07-26
• Letter: 2021-07-27

Application Sponsors

NDA 212516

SUN PHARMA GLOBAL

Marketing Status

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

Application Products

001	CAPSULE, DELAYED RELEASE;ORAL	EQ 20MG BASE	1	DRIZALMA SPRINKLE	DULOXETINE HYDROCHLORIDE
002	CAPSULE, DELAYED RELEASE;ORAL	EQ 30MG BASE	1	DRIZALMA SPRINKLE	DULOXETINE HYDROCHLORIDE
003	CAPSULE, DELAYED RELEASE;ORAL	EQ 40MG BASE	1	DRIZALMA SPRINKLE	DULOXETINE HYDROCHLORIDE
004	CAPSULE, DELAYED RELEASE;ORAL	EQ 60MG BASE	1	DRIZALMA SPRINKLE	DULOXETINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2019-07-19	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2021-07-23	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	15

CDER Filings

SUN PHARMA GLOBAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212516
            [companyName] => SUN PHARMA GLOBAL
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/212516s000lbl.pdf#page=42"]
            [products] => [{"drugName":"DRIZALMA SPRINKLE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"DRIZALMA SPRINKLE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 30MG BASE","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"DRIZALMA SPRINKLE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"DRIZALMA SPRINKLE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 60MG BASE","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/24\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212516s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/19\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212516s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212516s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212516Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/212516Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/24\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212516s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212516Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-06-24
        )

)