NDA 213978

OYSTER POINT PHARMA

FDA Drug Application

Application #213978

Documents

• Letter: 2021-10-19
• Label: 2021-10-20
• Review: 2022-06-03

Application Sponsors

NDA 213978

OYSTER POINT PHARMA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;NASAL

EQ 0.03MG BASE/SPRAY

1

TYRVAYA

VARENICLINE TARTRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2021-10-15

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

OYSTER POINT PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213978
            [companyName] => OYSTER POINT PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TYRVAYA","activeIngredients":"VARENICLINE TARTRATE","strength":"EQ 0.03MG BASE\/SPRAY","dosageForm":"SOLUTION;NASAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/15\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213978s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/15\/2021","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\\\/2021\\\/213978s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213978Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-10-15
        )

)