ANDA 075500

UPSHER SMITH LABS

FDA Drug Application

Application #075500

Documents

• Letter: 2001-04-27

Application Sponsors

ANDA 075500

UPSHER SMITH LABS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

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

FDA Submissions

	ORIG	1	AP	2001-04-27
LABELING; Labeling	SUPPL	2	AP	2003-05-13
LABELING; Labeling	SUPPL	14	AP	2015-03-02
LABELING; Labeling	SUPPL	15	AP	2015-03-02
LABELING; Labeling	SUPPL	17	AP	2021-02-04	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	14	Null	7
SUPPL	15	Null	7
SUPPL	17	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75500
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SORINE","activeIngredients":"SOTALOL HYDROCHLORIDE","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SORINE","activeIngredients":"SOTALOL HYDROCHLORIDE","strength":"160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SORINE","activeIngredients":"SOTALOL HYDROCHLORIDE","strength":"240MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SORINE","activeIngredients":"SOTALOL HYDROCHLORIDE","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SORINE","submission":"SOTALOL HYDROCHLORIDE","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SORINE","submission":"SOTALOL HYDROCHLORIDE","actionType":"160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SORINE","submission":"SOTALOL HYDROCHLORIDE","actionType":"240MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SORINE","submission":"SOTALOL HYDROCHLORIDE","actionType":"120MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)