ANDA 076041

SUN PHARM INDS LTD

FDA Drug Application

Application #076041

Documents

• Review: 2005-07-22
• Other Important Information from FDA: 2003-12-17
• Other: 2015-07-02
• Medication Guide: 2018-02-28

Application Sponsors

ANDA 076041

SUN PHARM INDS LTD

Marketing Status

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

Application Products

001	CAPSULE;ORAL	10MG	0	SOTRET	ISOTRETINOIN
002	CAPSULE;ORAL	20MG	0	SOTRET	ISOTRETINOIN
003	CAPSULE;ORAL	40MG	0	SOTRET	ISOTRETINOIN

FDA Submissions

	ORIG	1	AP	2002-12-24
LABELING; Labeling	SUPPL	2	AP	2005-08-12
LABELING; Labeling	SUPPL	3	AP	2007-02-06
LABELING; Labeling	SUPPL	4	AP	2007-02-06
LABELING; Labeling	SUPPL	5	AP	2007-11-02
LABELING; Labeling	SUPPL	6	AP	2009-08-20
LABELING; Labeling	SUPPL	7	AP	2010-03-25
REMS; REMS	SUPPL	8	AP	2010-10-22
REMS; REMS	SUPPL	18	AP	2012-04-12

Submissions Property Types

SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	18	Null	15

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76041
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/Sotret.pdf"]
            [products] => [{"drugName":"SOTRET","activeIngredients":"ISOTRETINOIN","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SOTRET","activeIngredients":"ISOTRETINOIN","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SOTRET","activeIngredients":"ISOTRETINOIN","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SOTRET","submission":"ISOTRETINOIN","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SOTRET","submission":"ISOTRETINOIN","actionType":"20MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SOTRET","submission":"ISOTRETINOIN","actionType":"40MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)