ANDA 075366

UPSHER SMITH LABS

FDA Drug Application

Application #075366

Documents

• Letter: 2000-05-01
• Letter: 2004-06-18
• Label: 2004-06-17
• Review: 2001-12-18

Application Sponsors

ANDA 075366

UPSHER SMITH LABS

Marketing Status

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

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
004	TABLET;ORAL	240MG	0	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2000-05-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-09-07
LABELING; Labeling	SUPPL	3	AP	2000-10-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-04-30
LABELING; Labeling	SUPPL	5	AP	2002-09-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2015-12-18
LABELING; Labeling	SUPPL	19	AP	2015-12-18	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	16	Null	7
SUPPL	19	Null	7

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75366
            [companyName] => UPSHER SMITH LABS
            [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"},{"drugName":"SOTALOL HYDROCHLORIDE","activeIngredients":"SOTALOL HYDROCHLORIDE","strength":"240MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/01\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2000\\\/75-366_Sotalol%20Hydrochloride_prntlbl.pdf\"}]","notes":""}]
            [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"},{"actionDate":"SOTALOL HYDROCHLORIDE","submission":"SOTALOL HYDROCHLORIDE","actionType":"240MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2000-05-01
        )

)