ANDA 040541

MYLAN INSTITUTIONAL

FDA Drug Application

Application #040541

Documents

• Letter: 2004-11-16

Application Sponsors

ANDA 040541

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	20MG/2ML (10MG/ML)	0	SOTRADECOL	SODIUM TETRADECYL SULFATE
002	INJECTABLE;INJECTION	60MG/2ML (30MG/ML)	0	SOTRADECOL	SODIUM TETRADECYL SULFATE

FDA Submissions

	ORIG	1	AP	2004-11-12
LABELING; Labeling	SUPPL	4	AP	2008-05-30
LABELING; Labeling	SUPPL	14	AP	2018-03-01	STANDARD
LABELING; Labeling	SUPPL	15	AP	2019-05-22	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	14	Null	15
SUPPL	15	Null	15

TE Codes

002

Prescription

AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40541
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"SOTRADECOL","activeIngredients":"SODIUM TETRADECYL SULFATE","strength":"20MG\/2ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"},{"drugName":"SOTRADECOL","activeIngredients":"SODIUM TETRADECYL SULFATE","strength":"60MG\/2ML (30MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SOTRADECOL","submission":"SODIUM TETRADECYL SULFATE","actionType":"20MG\/2ML (10MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SOTRADECOL","submission":"SODIUM TETRADECYL SULFATE","actionType":"60MG\/2ML (30MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)