ANDA 089673

RHODES PHARMS

FDA Drug Application

Application #089673

Application Sponsors

ANDA 089673

RHODES PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

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

FDA Submissions

	ORIG	1	AP	1988-02-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-05-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-01-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-06-22
LABELING; Labeling	SUPPL	5	AP	1996-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1997-12-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-05-16
LABELING; Labeling	SUPPL	18	AP	2007-09-12
LABELING; Labeling	SUPPL	19	AP	2011-06-28
LABELING; Labeling	SUPPL	21	AP	2013-08-02	STANDARD
LABELING; Labeling	SUPPL	22	AP	2013-10-18	STANDARD
LABELING; Labeling	SUPPL	23	AP	2017-05-26	STANDARD
LABELING; Labeling	SUPPL	24	AP	2017-05-26	STANDARD
LABELING; Labeling	SUPPL	25	AP	2017-08-29	STANDARD
LABELING; Labeling	SUPPL	26	AP	2018-09-21	STANDARD
REMS; REMS	SUPPL	27	AP	2019-02-04
LABELING; Labeling	SUPPL	28	AP	2019-10-07	STANDARD
LABELING; Labeling	SUPPL	29	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	19	Null	7
SUPPL	21	Null	15
SUPPL	22	Null	15
SUPPL	23	Null	7
SUPPL	24	Null	7
SUPPL	25	Null	7
SUPPL	26	Null	15
SUPPL	27	Null	15
SUPPL	28	Null	7
SUPPL	29	Null	7

CDER Filings

RHODES PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89673
            [companyName] => RHODES PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;60MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)