ANDA 088704

STI PHARMA LLC

FDA Drug Application

Application #088704

Documents

• Other: 2018-05-01

Application Sponsors

ANDA 088704

STI PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

10MG/5ML;30MG/5ML;1.25MG/5ML

0

TRIACIN-C

CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1985-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-12-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-12-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-03-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1989-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1989-06-07
LABELING; Labeling	SUPPL	10	AP	1990-05-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1992-06-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1990-09-28
LABELING; Labeling	SUPPL	13	AP	1992-09-11
LABELING; Labeling	SUPPL	16	AP	1992-01-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1994-06-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1995-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1998-08-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2000-10-02
LABELING; Labeling	SUPPL	33	AP	2015-07-08	STANDARD
LABELING; Labeling	SUPPL	34	AP	2017-01-13	STANDARD
LABELING; Labeling	SUPPL	35	AP	2017-03-15	STANDARD
LABELING; Labeling	SUPPL	36	AP	2017-03-15	STANDARD
LABELING; Labeling	SUPPL	37	AP	2017-08-29	STANDARD
LABELING; Labeling	SUPPL	38	AP	2018-06-28	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	33	Null	7
SUPPL	34	Null	7
SUPPL	35	Null	7
SUPPL	36	Null	15
SUPPL	37	Null	15
SUPPL	38	Null	7

CDER Filings

STI PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88704
            [companyName] => STI PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIACIN-C","activeIngredients":"CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE","strength":"10MG\/5ML;30MG\/5ML;1.25MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIACIN-C","submission":"CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE","actionType":"10MG\/5ML;30MG\/5ML;1.25MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)