ANDA 076438

SPECGX LLC

FDA Drug Application

Application #076438

Documents

• Other: 2015-06-30

Application Sponsors

ANDA 076438

SPECGX LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	100MG	0	MORPHINE SULFATE	MORPHINE SULFATE
002	TABLET, EXTENDED RELEASE;ORAL	200MG	0	MORPHINE SULFATE	MORPHINE SULFATE

FDA Submissions

	ORIG	1	AP	2003-07-03
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	7	AP	2009-07-22
LABELING; Labeling	SUPPL	9	AP	2014-08-13
REMS; REMS	SUPPL	10	AP	2012-07-09
LABELING; Labeling	SUPPL	11	AP	2012-07-09
REMS; REMS	SUPPL	12	AP	2013-04-15
LABELING; Labeling	SUPPL	13	AP	2014-06-25	STANDARD
REMS; REMS	SUPPL	15	AP	2014-08-19
LABELING; Labeling	SUPPL	16	AP	2015-05-16	STANDARD
REMS; REMS	SUPPL	17	AP	2015-06-26
REMS; REMS	SUPPL	19	AP	2016-04-20
LABELING; Labeling	SUPPL	21	AP	2016-11-03	STANDARD
REMS; REMS	SUPPL	22	AP	2016-09-30
REMS; REMS	SUPPL	23	AP	2017-05-26
REMS; REMS	SUPPL	25	AP	2018-09-18

Submissions Property Types

SUPPL	9	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	15
SUPPL	15	Null	31
SUPPL	16	Null	15
SUPPL	17	Null	15
SUPPL	19	Null	31
SUPPL	21	Null	15
SUPPL	22	Null	15
SUPPL	23	Null	15
SUPPL	25	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76438
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MORPHINE SULFATE","submission":"MORPHINE SULFATE","actionType":"100MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MORPHINE SULFATE","submission":"MORPHINE SULFATE","actionType":"200MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)