Application 021446

Type: NDA
Sponsor: PF PRISM CV

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LYRICA	PREGABALIN	CAPSULE;ORAL	25MG	Yes	No
002	LYRICA	PREGABALIN	CAPSULE;ORAL	50MG	Yes	No
003	LYRICA	PREGABALIN	CAPSULE;ORAL	75MG	Yes	No
004	LYRICA	PREGABALIN	CAPSULE;ORAL	100MG	Yes	No
005	LYRICA	PREGABALIN	CAPSULE;ORAL	150MG	Yes	No
006	LYRICA	PREGABALIN	CAPSULE;ORAL	200MG	Yes	No
007	LYRICA	PREGABALIN	CAPSULE;ORAL	225MG	Yes	No
008	LYRICA	PREGABALIN	CAPSULE;ORAL	300MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0071-1012	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1012	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1012	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1012	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1012	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1012	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1013	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1013	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1013	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1013	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1013	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1013	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1014	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1014	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1014	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1014	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1014	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1014	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1015	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1015	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1015	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1015	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1015	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1015	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1016	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1016	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1016	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1016	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1016	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1016	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1017	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1017	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1017	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1017	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1017	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1017	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1018	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1018	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1018	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1018	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1018	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1018	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1019	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1019	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1019	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1019	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1019	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1019	Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
21695-664	Lyrica	PREGABALIN	Rebel Distributors Corp	NDA	Current
35356-054	Lyrica	PREGABALIN	Quality Care Products, LLC	NDA	Current
43353-263	Lyrica	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-264	Lyrica	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-413	Lyrica	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-414	Lyrica	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-675	Lyrica	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-840	Lyrica	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-876	Lyrica	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
49999-895	Lyrica	PREGABALIN	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
49999-895	Lyrica	PREGABALIN	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
49999-906	Lyrica	PREGABALIN	Quality Care Products, LLC	NDA	Current
49999-906	Lyrica	PREGABALIN	Quality Care Products, LLC	NDA	Current
49999-949	Lyrica	PREGABALIN	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
50436-1265	Lyrica	PREGABALIN	Unit Dose Services	NDA	Current
50436-6523	Lyrica	PREGABALIN	Unit Dose Services	NDA	Current
50436-6523	Lyrica	PREGABALIN	Unit Dose Services	NDA	Current
50436-6524	Lyrica	PREGABALIN	Unit Dose Services	NDA	Current
50436-6525	Lyrica	PREGABALIN	Unit Dose Services	NDA	Current
50436-6526	Lyrica	PREGABALIN	Unit Dose Services	NDA	Current
50436-6527	Lyrica	PREGABALIN	Unit Dose Services	NDA	Current
50436-6528	Lyrica	PREGABALIN	Unit Dose Services	NDA	Current
55289-214	Lyrica	PREGABALIN	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-214	Lyrica	PREGABALIN	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-214	Lyrica	PREGABALIN	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-214	Lyrica	PREGABALIN	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-255	Lyrica	PREGABALIN	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-255	Lyrica	PREGABALIN	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-255	Lyrica	PREGABALIN	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-255	Lyrica	PREGABALIN	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-255	Lyrica	PREGABALIN	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-257	Lyrica	PREGABALIN	PD-Rx Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82108	SUPPL	2025-05-01
82062	SUPPL	2025-04-29
82061	SUPPL	2025-04-29
76827	SUPPL	2024-04-10
76790	SUPPL	2024-01-08
62515	SUPPL	2020-04-09
62448	SUPPL	2020-04-06
58855	SUPPL	2019-05-24
58853	SUPPL	2019-05-24
58852	SUPPL	2019-05-24
54039	SUPPL	2018-05-08
54023	SUPPL	2018-05-04
54022	SUPPL	2018-05-04
50038	SUPPL	2017-10-12
46528	SUPPL	2016-12-23
46515	SUPPL	2016-12-22
36965	SUPPL	2016-03-15
27825	SUPPL	2016-03-11
27824	SUPPL	2013-12-26
15503	SUPPL	2013-12-24
24201	SUPPL	2012-07-06
21666	SUPPL	2012-07-06
36964	SUPPL	2012-06-21
5417	SUPPL	2012-06-21
36963	SUPPL	2011-08-30
27823	SUPPL	2011-08-26
15502	SUPPL	2011-07-07
5416	SUPPL	2011-06-29
36962	SUPPL	2011-04-29
27822	SUPPL	2011-04-29
27821	SUPPL	2011-04-29
15501	SUPPL	2011-04-29
36961	SUPPL	2010-10-25
5415	SUPPL	2010-10-19
36960	SUPPL	2010-01-08
5414	SUPPL	2010-01-06
36959	SUPPL	2009-05-12
15500	SUPPL	2009-05-12
27820	SUPPL	2009-05-04
5413	SUPPL	2009-05-04
5412	SUPPL	2007-07-05
36958	SUPPL	2007-06-27
27819	SUPPL	2006-11-06
27818	SUPPL	2006-03-01
5411	SUPPL	2006-03-01
36957	SUPPL	2006-02-22
15499	SUPPL	2006-02-22
24148	ORIG	2005-11-30
21665	ORIG	2005-07-18
27817	ORIG	2005-01-11
51601	SUPPL	1900-01-01
51600	SUPPL	1900-01-01
51599	SUPPL	1900-01-01

Application 021446

Related Records#

Application Products#

NDC Listings For This Application#

Documents#