ANDA 205268

GLENMARK PHARMS LTD

FDA Drug Application

Application #205268

Application Sponsors

ANDA 205268

GLENMARK PHARMS LTD

Marketing Status

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

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	225MG	0	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	325MG	0	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	425MG	0	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-09-08

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205268
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"225MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"325MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"425MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/08\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/31\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-31
        )

)