NDA 211746

GLENMARK SPECIALTY SA

FDA Drug Application

Application #211746

Documents

• Letter: 2022-01-18
• Label: 2022-01-18
• Letter: 2022-10-03
• Label: 2022-10-05
• Review: 2023-01-10

Application Sponsors

NDA 211746

GLENMARK SPECIALTY SA

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

665MCG/25MCG

0

RYALTRIS

OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE MONOHYDRATE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2022-01-13	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2022-09-30	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	15

CDER Filings

GLENMARK SPECIALTY SA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211746
            [companyName] => GLENMARK SPECIALTY SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RYALTRIS","activeIngredients":"OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE MONOHYDRATE","strength":"665MCG\/25MCG","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/13\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/211746s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/211746s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/211746Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-01-13
        )

)