ANDA 074862

RHODES PHARMS

FDA Drug Application

Application #074862

Documents

• Letter: 1998-07-07
• Label: 1998-07-07
• Other: 2015-06-30
• Review: 1999-03-30

Application Sponsors

ANDA 074862

RHODES PHARMS

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	15MG	0	MORPHINE SULFATE	MORPHINE SULFATE
002	TABLET, EXTENDED RELEASE;ORAL	30MG	0	MORPHINE SULFATE	MORPHINE SULFATE
003	TABLET, EXTENDED RELEASE;ORAL	60MG	0	MORPHINE SULFATE	MORPHINE SULFATE

FDA Submissions

	ORIG	1	AP	1998-07-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-07-11
REMS; REMS	SUPPL	10	AP	2012-07-09
LABELING; Labeling	SUPPL	12	AP	2012-09-28
REMS; REMS	SUPPL	13	AP	2013-04-15
LABELING; Labeling	SUPPL	19	AP	2014-07-21	STANDARD
REMS; REMS	SUPPL	20	AP	2014-08-19
REMS; REMS	SUPPL	22	AP	2015-06-26
REMS; REMS	SUPPL	23	AP	2016-04-20
REMS; REMS	SUPPL	26	AP	2016-09-30
REMS; REMS	SUPPL	27	AP	2017-05-26
REMS; REMS	SUPPL	28	AP	2018-09-18

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	7
SUPPL	12	Null	15
SUPPL	13	Null	7
SUPPL	19	Null	15
SUPPL	20	Null	7
SUPPL	22	Null	7
SUPPL	23	Null	7
SUPPL	26	Null	15
SUPPL	27	Null	15
SUPPL	28	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

RHODES PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74862
            [companyName] => RHODES PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"15MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"60MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/07\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/98\\\/74862ap_appltr_prntlbl_chemr.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MORPHINE SULFATE","submission":"MORPHINE SULFATE","actionType":"15MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MORPHINE SULFATE","submission":"MORPHINE SULFATE","actionType":"30MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MORPHINE SULFATE","submission":"MORPHINE SULFATE","actionType":"60MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1998-07-07
        )

)