ANDA 214415

RUBICON

FDA Drug Application

Application #214415

Application Sponsors

ANDA 214415

RUBICON

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	5MG	0	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	10MG	0	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	15MG	0	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-10-27	STANDARD
LABELING; Labeling	SUPPL	4	AP	2023-01-27	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

RUBICON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214415
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYBUTYNIN CHLORIDE","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYBUTYNIN CHLORIDE","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYBUTYNIN CHLORIDE","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"15MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-27
        )

)