NDA 206185

SUN PHARMA GLOBAL

FDA Drug Application

Application #206185

Documents

• Letter: 2018-09-14
• Label: 2018-09-14
• Review: 2019-05-28
• Letter: 2020-12-23
• Label: 2020-12-28

Application Sponsors

NDA 206185

SUN PHARMA GLOBAL

Marketing Status

• Prescription: 001

Application Products

001

EMULSION;OPHTHALMIC

0.005%

1

XELPROS

LATANOPROST

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2018-09-12	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-12-21	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	9	Null	6

CDER Filings

SUN PHARMA GLOBAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206185
            [companyName] => SUN PHARMA GLOBAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"XELPROS","activeIngredients":"LATANOPROST","strength":"0.005%","dosageForm":"EMULSION;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/12\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206185s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/12\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206185s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206185Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/206185Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-09-12
        )

)