ANDA 203506

SUN PHARM INDS LTD

FDA Drug Application

Application #203506

Documents

• Letter: 2015-04-28
• Other: 2015-06-30

Application Sponsors

ANDA 203506

SUN PHARM INDS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 006
• Discontinued: 007

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	5MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	7.5MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	10MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE;ORAL	15MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
005	TABLET, EXTENDED RELEASE;ORAL	20MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
006	TABLET, EXTENDED RELEASE;ORAL	30MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
007	TABLET, EXTENDED RELEASE;ORAL	40MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-04-24
REMS; REMS	SUPPL	2	AP	2016-04-20
LABELING; Labeling	SUPPL	3	AP	2016-12-16	STANDARD
REMS; REMS	SUPPL	4	AP	2016-09-30
LABELING; Labeling	SUPPL	5	AP	2016-12-16	STANDARD
REMS; REMS	SUPPL	7	AP	2017-05-26

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	7	Null	15

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203506
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"7.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"15MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/24\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203506Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/26\/2017","submission":"SUPPL-7","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/30\/2016","submission":"SUPPL-4","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/20\/2016","submission":"SUPPL-2","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2015","submission":"SUPPL-1","supplementCategories":"REMS-Proposal","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-05-26
        )

)