NDA 205223

CHEMO RESEARCH SL

FDA Drug Application

Application #205223

Documents

• Letter: 2014-03-25
• Summary Review: 2014-10-07
• Label: 2014-03-25
• Review: 2014-10-07
• Label: 2018-08-06
• Letter: 2018-08-07
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 2020-05-20
• Letter: 2021-12-07
• Label: 2021-12-14
• Letter: 2022-02-28
• Label: 2022-03-01

Application Sponsors

NDA 205223

CHEMO RESEARCH SL

Marketing Status

• Prescription: 001

Application Products

001

GEL;VAGINAL

1.3%

1

NUVESSA

METRONIDAZOLE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2014-03-24	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2018-08-03	PRIORITY
LABELING; Labeling	SUPPL	5	AP	2021-12-06	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-02-25	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	6

CDER Filings

CHEMO RESEARCH SL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205223
            [companyName] => CHEMO RESEARCH SL
            [docInserts] => ["",""]
            [products] => [{"drugName":"NUVESSA","activeIngredients":"METRONIDAZOLE","strength":"1.3%","dosageForm":"GEL;VAGINAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/03\/2018","submission":"SUPPL-2","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205223s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205223s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/24\/2014","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\\\/2014\\\/205223s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205223Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205223Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205223Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/03\/2018","submission":"SUPPL-2","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205223s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205223Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"12\/14\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-08-03
        )

)