ANDA 211655

AJANTA PHARMA LTD

FDA Drug Application

Application #211655

Application Sponsors

ANDA 211655

AJANTA PHARMA LTD

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	2019-02-28	STANDARD
LABELING; Labeling	SUPPL	16	AP	2022-08-25	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	16	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

AJANTA PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211655
            [companyName] => AJANTA PHARMA LTD
            [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":"02\/28\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/28\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-28
        )

)