ANDA 075515

SUN PHARM INDUSTRIES

FDA Drug Application

Application #075515

Documents

• Letter: 2003-04-14

Application Sponsors

ANDA 075515

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	80MG	0	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE
002	TABLET;ORAL	160MG	0	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE
003	TABLET;ORAL	240MG	0	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE
004	TABLET;ORAL	120MG	0	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2001-10-15
LABELING; Labeling	SUPPL	3	AP	2003-04-07
LABELING; Labeling	SUPPL	5	AP	2004-08-06

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75515
            [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":"160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SOTALOL HYDROCHLORIDE","activeIngredients":"SOTALOL HYDROCHLORIDE","strength":"240MG","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"}]
            [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":"160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SOTALOL HYDROCHLORIDE","submission":"SOTALOL HYDROCHLORIDE","actionType":"240MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SOTALOL HYDROCHLORIDE","submission":"SOTALOL HYDROCHLORIDE","actionType":"120MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)