ANDA 080154

QUAGEN

FDA Drug Application

Application #080154

Application Sponsors

ANDA 080154

QUAGEN

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

PROPYLTHIOURACIL

PROPYLTHIOURACIL

FDA Submissions

	ORIG	1	AP	1971-07-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1983-01-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1984-11-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1985-11-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1995-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1995-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1995-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1995-01-31
LABELING; Labeling	SUPPL	22	AP	1995-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1999-02-17
LABELING; Labeling	SUPPL	26	AP	1999-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1998-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2001-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2001-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2002-03-12
LABELING; Labeling	SUPPL	32	AP	2002-11-21
LABELING; Labeling	SUPPL	36	AP	2010-12-29
LABELING; Labeling	SUPPL	37	AP	2011-08-22
LABELING; Labeling	SUPPL	39	AP	2016-11-30	STANDARD
LABELING; Labeling	SUPPL	42	AP	2016-11-30	STANDARD
LABELING; Labeling	SUPPL	43	AP	2020-08-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	2021-03-18	UNKNOWN

Submissions Property Types

SUPPL	7	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	37	Null	15
SUPPL	39	Null	7
SUPPL	42	Null	15
SUPPL	43	Null	15
SUPPL	44	Null	7

TE Codes

001

Prescription

BD

CDER Filings

QUAGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80154
            [companyName] => QUAGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPYLTHIOURACIL","activeIngredients":"PROPYLTHIOURACIL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROPYLTHIOURACIL","submission":"PROPYLTHIOURACIL","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)