Documents
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
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
)
)