ANDA 040419

SPECGX LLC

FDA Drug Application

Application #040419

Documents

• Letter: 2001-05-31

Application Sponsors

ANDA 040419

SPECGX LLC

Marketing Status

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

Application Products

001	TABLET;ORAL	300MG;15MG	0	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE
002	TABLET;ORAL	300MG;30MG	0	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE
003	TABLET;ORAL	300MG;60MG	0	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE

FDA Submissions

	ORIG	1	AP	2001-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-12-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-12-13
LABELING; Labeling	SUPPL	4	AP	2002-12-13
LABELING; Labeling	SUPPL	10	AP	2007-11-30
LABELING; Labeling	SUPPL	11	AP	2008-02-21
LABELING; Labeling	SUPPL	12	AP	2011-06-22
LABELING; Labeling	SUPPL	14	AP	2013-05-10	STANDARD
LABELING; Labeling	SUPPL	16	AP	2013-10-18	STANDARD
LABELING; Labeling	SUPPL	17	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	19	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	21	AP	2018-04-06	STANDARD
LABELING; Labeling	SUPPL	23	AP	2018-04-06	STANDARD
REMS; REMS	SUPPL	24	AP	2018-09-18
LABELING; Labeling	SUPPL	25	AP	2018-09-20	STANDARD
LABELING; Labeling	SUPPL	26	AP	2019-10-07	STANDARD
LABELING; Labeling	SUPPL	29	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	12	Null	7
SUPPL	14	Null	7
SUPPL	16	Null	7
SUPPL	17	Null	15
SUPPL	19	Null	7
SUPPL	21	Null	7
SUPPL	23	Null	7
SUPPL	24	Null	7
SUPPL	25	Null	15
SUPPL	26	Null	15
SUPPL	29	Null	7

TE Codes

001	Prescription	AA
002	Prescription	AA
003	Prescription	AA

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40419
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;60MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)