ANDA 207428

BEXIMCO PHARMS USA

FDA Drug Application

Application #207428

Application Sponsors

ANDA 207428

BEXIMCO PHARMS USA

Marketing Status

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

Application Products

001	TABLET;ORAL	80MG	0	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE
002	TABLET;ORAL	120MG	0	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE
003	TABLET;ORAL	160MG	0	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-10-21

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

BEXIMCO PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207428
            [companyName] => BEXIMCO PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SOTALOL HYDROCHLORIDE","activeIngredients":"SOTALOL HYDROCHLORIDE","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SOTALOL HYDROCHLORIDE","activeIngredients":"SOTALOL HYDROCHLORIDE","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SOTALOL HYDROCHLORIDE","activeIngredients":"SOTALOL HYDROCHLORIDE","strength":"160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/21\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-10-21
        )

)