Application 020538

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESTRADIOL	ESTRADIOL	Film, Extended Release; Transdermal	0.0375MG/24HR	No	No
002	ESTRADIOL	ESTRADIOL	Film, Extended Release; Transdermal	0.075MG/24HR	No	No
003	ESTRADIOL	ESTRADIOL	Film, Extended Release; Transdermal	0.05MG/24HR	No	No
004	ESTRADIOL	ESTRADIOL	Film, Extended Release; Transdermal	0.1MG/24HR	No	No
005	VIVELLE-DOT	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.0375MG/24HR	Yes	No
006	VIVELLE-DOT	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.05MG/24HR	Yes	No
007	VIVELLE-DOT	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.075MG/24HR	Yes	No
008	VIVELLE-DOT	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/24HR	Yes	Yes
009	VIVELLE-DOT	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.025MG/24HR	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0343	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0343	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0343	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0343	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0343	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0344	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0344	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0344	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0344	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0344	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0345	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0345	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0345	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0345	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0345	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0346	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0346	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0346	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0346	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0346	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0365	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0365	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0365	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0365	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0365	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0781-7129	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7129	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7129	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7129	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7129	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7138	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7138	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7138	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7138	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7138	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7144	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7144	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7144	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7144	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7144	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7156	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7156	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7156	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7156	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7156	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7167	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7167	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7167	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7167	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7167	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
68071-3326	Estradiol	estradiol	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-3326	Estradiol	estradiol	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77569	SUPPL	2024-02-20
77546	SUPPL	2024-02-16
69008	SUPPL	2021-10-15
68886	SUPPL	2021-10-05
68885	SUPPL	2021-10-05
68874	SUPPL	2021-10-05
68873	SUPPL	2021-10-05
68541	SUPPL	2021-09-03
50287	SUPPL	2017-11-03
12696	SUPPL	2014-08-01
2687	SUPPL	2014-08-01
34795	SUPPL	2013-05-21
34794	SUPPL	2013-05-21
25134	SUPPL	2013-05-21
25133	SUPPL	2013-05-21
12695	SUPPL	2013-05-21
2686	SUPPL	2013-05-21
41418	SUPPL	2006-05-16
25132	SUPPL	2004-08-10
12694	SUPPL	2004-08-10
12693	SUPPL	2004-02-03
25131	SUPPL	2004-02-02
34793	SUPPL	2002-05-03
34792	SUPPL	2002-05-03
34791	SUPPL	2002-05-03
2685	SUPPL	2002-05-03
2684	SUPPL	2002-05-03
2683	SUPPL	2002-05-03
20708	SUPPL	1999-01-08
12692	SUPPL	1999-01-08
2682	SUPPL	1999-01-08

Application 020538

Related Records#

Application Products#

NDC Listings For This Application#

Documents#