NDA 209363

LUPIN

FDA Drug Application

Application #209363

Documents

• Letter: 2017-09-15
• Label: 2017-09-15
• Review: 2017-10-13
• Letter: 2021-06-15
• Label: 2021-06-15
• Letter: 2021-07-01
• Label: 2021-07-07
• Label: 2021-12-17
• Letter: 2021-12-21
• Label: 2022-01-27
• Label: 2022-01-27
• Letter: 2022-01-27
• Letter: 2022-01-27

Application Sponsors

NDA 209363

LUPIN

Marketing Status

• Prescription: 001

Application Products

001

GRANULE;ORAL

2GM/PACKET

1

SOLOSEC

SECNIDAZOLE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2017-09-15	PRIORITY
EFFICACY; Efficacy	SUPPL	12	AP	2021-06-30	STANDARD
EFFICACY; Efficacy	SUPPL	14	AP	2022-01-26	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-06-14	STANDARD
EFFICACY; Efficacy	SUPPL	16	AP	2022-01-26	STANDARD
LABELING; Labeling	SUPPL	17	AP	2021-12-15	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	12	Null	15
SUPPL	14	Null	7
SUPPL	15	Null	15
SUPPL	16	Null	15
SUPPL	17	Null	15

CDER Filings

LUPIN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209363
            [companyName] => LUPIN
            [docInserts] => ["",""]
            [products] => [{"drugName":"SOLOSEC","activeIngredients":"SECNIDAZOLE","strength":"2GM\/PACKET","dosageForm":"GRANULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/26\/2022","submission":"SUPPL-16","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209363Orig1s014s016lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2022","submission":"SUPPL-14","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209363Orig1s014s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2021","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209363s017lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2021","submission":"SUPPL-17","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209363s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2021","submission":"SUPPL-12","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209363s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2021","submission":"SUPPL-15","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209363s015lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2021","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209363s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209363s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/15\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209363s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209363Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209363Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/15\/2021","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209363s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/209363Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"01\/26\/2022","submission":"SUPPL-16","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209363Orig1s014s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"06\/14\/2021","submission":"SUPPL-15","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209363s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/209363Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"01\/26\/2022","submission":"SUPPL-14","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209363Orig1s014s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"06\/30\/2021","submission":"SUPPL-12","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209363s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/209363Orig1s012ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2022-01-26
        )

)