NDA 209875

LUPIN LTD

FDA Drug Application

Application #209875

Documents

• Label: 2017-08-08
• Letter: 2017-08-08
• Review: 2017-09-25
• Letter: 2020-05-06
• Label: 2020-05-06
• Letter: 2020-09-28
• Label: 2020-09-29

Application Sponsors

NDA 209875

LUPIN LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	EQ 1MG BASE	1	NIKITA	PITAVASTATIN SODIUM
002	TABLET;ORAL	EQ 2MG BASE	1	NIKITA	PITAVASTATIN SODIUM
003	TABLET;ORAL	EQ 4MG BASE	1	NIKITA	PITAVASTATIN SODIUM

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2017-08-04	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-09-25	901 REQUIRED

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209875
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIKITA","activeIngredients":"PITAVASTATIN SODIUM","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"NIKITA","activeIngredients":"PITAVASTATIN SODIUM","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"NIKITA","activeIngredients":"PITAVASTATIN SODIUM","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/05\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209875s001lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209875s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/04\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209875s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209875Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209875Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/05\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209875s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209875Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-05-05
        )

)