NDA 212520

RVL PHARMA INC

FDA Drug Application

Application #212520

Documents

• Label: 2020-07-09
• Letter: 2020-07-09
• Label: 2020-08-17
• Letter: 2020-08-17
• Review: 2021-04-07
• Label: 2021-05-05
• Letter: 2021-05-07

Application Sponsors

NDA 212520

RVL PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;OPHTHALMIC

0.1%

2

UPNEEQ

OXYMETAZOLINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-07-08	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-08-14	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-05-05	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6
SUPPL	4	Null	15

CDER Filings

RVL PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212520
            [companyName] => RVL PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"UPNEEQ","activeIngredients":"OXYMETAZOLINE HYDROCHLORIDE","strength":"0.1%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"07\/08\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/0212520s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/08\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/0212520s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212520Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-07-08
        )

)