ANDA 076576

SUN PHARM INDUSTRIES

FDA Drug Application

Application #076576

Application Sponsors

ANDA 076576

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 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

ORIG

1

AP

2004-04-08

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76576
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"SOTALOL HYDROCHLORIDE","activeIngredients":"SOTALOL HYDROCHLORIDE","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SOTALOL HYDROCHLORIDE","activeIngredients":"SOTALOL HYDROCHLORIDE","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SOTALOL HYDROCHLORIDE","activeIngredients":"SOTALOL HYDROCHLORIDE","strength":"160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SOTALOL HYDROCHLORIDE","submission":"SOTALOL HYDROCHLORIDE","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SOTALOL HYDROCHLORIDE","submission":"SOTALOL HYDROCHLORIDE","actionType":"120MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SOTALOL HYDROCHLORIDE","submission":"SOTALOL HYDROCHLORIDE","actionType":"160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)