ANDA 076412

SPECGX LLC

FDA Drug Application

Application #076412

Documents

• Other: 2015-06-30

Application Sponsors

ANDA 076412

SPECGX LLC

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	2003-07-31
LABELING; Labeling	SUPPL	2	AP	2004-03-19
LABELING; Labeling	SUPPL	3	AP	2003-11-06
LABELING; Labeling	SUPPL	5	AP	2004-09-30
LABELING; Labeling	SUPPL	10	AP	2009-07-22
LABELING; Labeling	SUPPL	11	AP	2014-08-13
REMS; REMS	SUPPL	12	AP	2012-07-09
LABELING; Labeling	SUPPL	13	AP	2012-07-09
REMS; REMS	SUPPL	14	AP	2013-04-15
LABELING; Labeling	SUPPL	15	AP	2014-06-25	STANDARD
REMS; REMS	SUPPL	18	AP	2014-08-19
LABELING; Labeling	SUPPL	19	AP	2015-05-16	STANDARD
REMS; REMS	SUPPL	20	AP	2015-06-26
REMS; REMS	SUPPL	22	AP	2016-04-20
LABELING; Labeling	SUPPL	24	AP	2016-11-03	STANDARD
REMS; REMS	SUPPL	25	AP	2016-09-30
REMS; REMS	SUPPL	26	AP	2017-05-26
REMS; REMS	SUPPL	28	AP	2018-09-18

Submissions Property Types

SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	15
SUPPL	18	Null	15
SUPPL	19	Null	15
SUPPL	20	Null	15
SUPPL	22	Null	15
SUPPL	24	Null	15
SUPPL	25	Null	15
SUPPL	26	Null	7
SUPPL	28	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76412
            [companyName] => SPECGX LLC
            [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] => 
            [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] => 1969-12-31
        )

)