Application 022122

Type: NDA
Sponsor: GLAXOSMITHKLINE CONS

Related Records

Company: GLAXOSMITHKLINE CONS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VOLTAREN ARTHRITIS PAIN	DICLOFENAC SODIUM	GEL;TOPICAL	1%	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0067-8152	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8152	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8152	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8152	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8152	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8152	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8152	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8153	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8153	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8153	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8153	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8153	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8153	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8153	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
21695-791	Voltaren	diclofenac sodium	Rebel Distributors Corp	NDA	Current
35356-187	Voltaren	diclofenac sodium	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
35356-187	Voltaren	diclofenac sodium	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
49884-935	Diclofenac Sodium	diclofenac sodium	Par Pharmaceutical Inc	NDA AUTHORIZED GENERIC	Current
49884-935	Diclofenac Sodium	diclofenac sodium	Par Pharmaceutical Inc	NDA AUTHORIZED GENERIC	Current
49884-935	Diclofenac Sodium	diclofenac sodium	Par Pharmaceutical Inc	NDA AUTHORIZED GENERIC	Current
50090-1099	Voltaren	diclofenac sodium	A-S Medication Solutions	NDA	Current
50090-2801	Diclofenac Sodium	diclofenac sodium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2801	Diclofenac Sodium	diclofenac sodium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-4246	Diclofenac Sodium	diclofenac sodium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50436-3621	Voltaren	diclofenac sodium	Unit Dose Services	NDA	Current
55700-528	Diclofenac Sodium	diclofenac sodium	Lake Erie Medical DBA Quality Care Products LLC	NDA AUTHORIZED GENERIC	Current
55700-528	Diclofenac Sodium	diclofenac sodium	Lake Erie Medical DBA Qua	NDA AUTHORIZED	Current
61919-592	VOLTAREN	VOLTAREN	DIRECT RX	NDA	Current
63187-582	Voltaren	diclofenac sodium	Proficient Rx LP	NDA	Current
63187-582	Voltaren	diclofenac sodium	Proficient Rx LP	NDA	Current
63187-753	Diclofenac Sodium	diclofenac sodium	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
63187-753	Diclofenac Sodium	diclofenac sodium	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
63481-684	Voltaren	diclofenac sodium	Endo Pharmaceuticals Inc.	NDA	Current
63481-684	Voltaren	diclofenac sodium	Endo Pharmaceuticals Inc.	NDA	Current
63481-684	Voltaren	diclofenac sodium	Endo Pharmaceuticals Inc.	NDA	Current
63629-4941	Voltaren	diclofenac sodium	Bryant Ranch Prepack	NDA	Current
63629-4941	Voltaren	diclofenac sodium	Bryant Ranch Prepack	NDA	Current
63629-7069	Diclofenac Sodium	diclofenac sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-7069	Diclofenac Sodium	diclofenac sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
68071-4382	Diclofenac Sodium	diclofenac sodium	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-4382	Diclofenac Sodium	diclofenac sodium	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68387-456	Voltaren	diclofenac sodium	Keltman Pharmaceuticals Inc.	NDA	Current
68788-9338	Voltaren	diclofenac sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
69621-814	Diclo Gel 1% with Xrylix Sheets	diclofenac sodium	Shoreline Pharmaceuticals, Inc.	NDA	Current
70518-1578	Voltaren	diclofenac sodium	REMEDYREPACK INC.	NDA	Current
70518-1578	Voltaren	diclofenac sodium	REMEDYREPACK INC.	NDA	Current

Documents

Document	Submission type	Date
79355	SUPPL	2024-08-09
79347	SUPPL	2024-08-09
76868	SUPPL	2023-12-15
76698	SUPPL	2023-12-15
73593	SUPPL	2023-02-22
73591	SUPPL	2023-02-22
72718	SUPPL	2022-11-27
72698	SUPPL	2022-11-25
69284	SUPPL	2021-11-09
69233	SUPPL	2021-11-05
68561	SUPPL	2021-09-08
68555	SUPPL	2021-09-08
65923	SUPPL	2021-01-19
65596	SUPPL	2020-12-15
61903	SUPPL	2020-02-14
61902	SUPPL	2020-02-14
54453	SUPPL	2018-06-05
52725	SUPPL	2018-02-26
52694	SUPPL	2018-02-23
52693	SUPPL	2018-02-23
29295	SUPPL	2016-05-11
16989	SUPPL	2016-05-11
16988	SUPPL	2015-01-05
29294	SUPPL	2014-11-28
29293	SUPPL	2009-11-10
38287	SUPPL	2009-10-01
42424	ORIG	2008-02-22
24245	ORIG	2008-02-22
29292	ORIG	2007-10-22
16987	ORIG	2007-10-22