ANDA 088764

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #088764

Documents

• Label: 2013-09-04
• Letter: 2013-09-04

Application Sponsors

ANDA 088764

ACTAVIS MID ATLANTIC

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

10MG/5ML;5MG/5ML;6.25MG/5ML

0

PROMETH VC W/ CODEINE

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1984-10-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-08-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-02-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-04-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-04-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1986-06-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1987-03-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1988-12-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1988-12-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1990-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1990-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1990-10-03
LABELING; Labeling	SUPPL	18	AP	1989-11-06
LABELING; Labeling	SUPPL	19	AP	1990-02-07
LABELING; Labeling	SUPPL	20	AP	1990-03-29
LABELING; Labeling	SUPPL	21	AP	1991-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1990-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1991-01-23
LABELING; Labeling	SUPPL	25	AP	1992-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1994-02-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1996-05-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1996-05-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1996-05-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1996-05-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1995-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1996-05-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1996-05-07
LABELING; Labeling	SUPPL	34	AP	1996-05-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1996-06-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1997-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1997-09-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1998-11-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1998-11-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1998-11-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1998-12-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	2000-10-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	2001-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2001-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	2002-07-15
LABELING; Labeling	SUPPL	49	AP	2003-06-06
LABELING; Labeling	SUPPL	53	AP	2005-05-02
LABELING; Labeling	SUPPL	63	AP	2005-10-06
LABELING; Labeling	SUPPL	75	AP	2011-08-01
LABELING; Labeling	SUPPL	77	AP	2009-03-20
LABELING; Labeling	SUPPL	81	AP	2013-05-03
LABELING; Labeling	SUPPL	84	AP	2013-05-10	STANDARD
LABELING; Labeling	SUPPL	85	AP	2017-01-13	STANDARD
LABELING; Labeling	SUPPL	86	AP	2017-08-29	STANDARD
LABELING; Labeling	SUPPL	87	AP	2018-06-08	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	81	Null	15
SUPPL	84	Null	15
SUPPL	85	Null	7
SUPPL	86	Null	7
SUPPL	87	Null	7

TE Codes

001

Prescription

AA

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88764
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMETH VC W\/ CODEINE","activeIngredients":"CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE","strength":"10MG\/5ML;5MG\/5ML;6.25MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/10\/2013","submission":"SUPPL-84","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/088764Orig1s084lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PROMETH VC W\/ CODEINE","submission":"CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE","actionType":"10MG\/5ML;5MG\/5ML;6.25MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2013-05-10
        )

)