NDA 017962

US PHARMS HOLDINGS I

FDA Drug Application

Application #017962

Documents

• Label: 2005-11-17
• Label: 2012-01-06
• Letter: 2005-11-17
• Letter: 2005-11-17
• Letter: 2012-01-06
• Letter: 2012-01-06
• Review: 2006-05-08
• Label: 2005-11-17
• Label: 2012-01-06
• Review: 2006-05-08
• Letter: 2019-12-17
• Label: 2020-01-03
• Label: 2021-07-13
• Letter: 2021-07-14

Application Sponsors

NDA 017962

US PHARMS HOLDINGS I

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 2.5MG BASE	1	PARLODEL	BROMOCRIPTINE MESYLATE
002	CAPSULE;ORAL	EQ 5MG BASE	1	PARLODEL	BROMOCRIPTINE MESYLATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1978-06-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1979-02-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1979-02-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1979-05-17	PRIORITY
LABELING; Labeling	SUPPL	5	AP	1981-09-23
REMS; REMS	SUPPL	6	AP	1981-09-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1982-07-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1981-02-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1981-02-06	PRIORITY
LABELING; Labeling	SUPPL	10	AP	1984-12-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1982-03-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1981-06-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1984-02-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1982-08-26	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1982-07-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1982-07-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1983-11-30	PRIORITY
EFFICACY; Efficacy	SUPPL	18	AP	1985-06-28
LABELING; Labeling	SUPPL	19	AP	1984-12-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1985-09-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1987-01-21	PRIORITY
LABELING; Labeling	SUPPL	22	AP	1987-01-28
LABELING; Labeling	SUPPL	25	AP	1987-07-01
LABELING; Labeling	SUPPL	27	AP	1991-12-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1990-06-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1989-12-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1989-03-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1990-10-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1990-10-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1990-10-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1992-06-09	PRIORITY
LABELING; Labeling	SUPPL	36	AP	1992-05-29
LABELING; Labeling	SUPPL	37	AP	1991-12-11
LABELING; Labeling	SUPPL	38	AP	1992-05-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1993-04-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1993-04-01	PRIORITY
LABELING; Labeling	SUPPL	42	AP	1994-05-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1995-03-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1994-07-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1995-06-09	PRIORITY
LABELING; Labeling	SUPPL	47	AP	1995-02-08	STANDARD
LABELING; Labeling	SUPPL	48	AP	1995-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1995-10-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1995-11-28	PRIORITY
LABELING; Labeling	SUPPL	51	AP	1996-07-03	STANDARD
LABELING; Labeling	SUPPL	52	AP	1998-04-02	STANDARD
LABELING; Labeling	SUPPL	53	AP	1999-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1998-08-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1998-09-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	1999-04-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	1999-09-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1999-10-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	2000-05-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	2001-05-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	61	AP	2001-11-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	2002-02-21	PRIORITY
LABELING; Labeling	SUPPL	63	AP	2005-11-09	STANDARD
LABELING; Labeling	SUPPL	64	AP	2005-11-09	STANDARD
LABELING; Labeling	SUPPL	65	AP	2012-01-05	STANDARD
LABELING; Labeling	SUPPL	68	AP	2012-01-05	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	71	AP	2013-07-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	72	AP	2014-02-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	74	AP	2016-06-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	75	AP	2014-11-26	PRIORITY
LABELING; Labeling	SUPPL	81	AP	2019-12-13	STANDARD
LABELING; Labeling	SUPPL	83	AP	2021-07-12	STANDARD

Submissions Property Types

SUPPL	1	Null	0
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	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	54	Null	0
SUPPL	55	Null	0
SUPPL	56	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	0
SUPPL	59	Null	0
SUPPL	60	Null	0
SUPPL	61	Null	0
SUPPL	62	Null	0
SUPPL	65	Null	6
SUPPL	68	Null	6
SUPPL	71	Null	0
SUPPL	72	Null	0
SUPPL	74	Null	0
SUPPL	75	Null	0
SUPPL	81	Null	7
SUPPL	83	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

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            [ApplNo] => 17962
            [companyName] => 
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            [products] => []
            [labels] => 
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            [supplements] => 
            [actionDate] => 0000-00-00
        )

)