Application 020375

Type: NDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLIMARA	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.05MG/24HR	Yes	No
002	CLIMARA	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/24HR	Yes	Yes
003	CLIMARA	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.075MG/24HR	Yes	No
004	CLIMARA	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.025MG/24HR	Yes	No
005	CLIMARA	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.0375MG/24HR	Yes	No
006	CLIMARA	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.06MG/24HR	Yes	No
007	MENOSTAR	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.014MG/24HR	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-7104	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7104	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7104	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7104	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7104	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7119	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7119	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7119	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7119	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7119	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7122	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7122	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7122	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7122	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7122	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7133	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7133	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7133	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7133	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7133	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7134	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7134	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7134	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7134	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7134	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7136	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7136	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7136	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7136	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7136	Estradiol Transdermal System	Estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
47781-204	Estradiol Transdermal System	Estradiol	Alvogen, Inc.	NDA	Current
47781-204	Estradiol Transdermal System	Estradiol	Alvogen, Inc.	NDA	Current
47781-205	Estradiol Transdermal System	Estradiol	Alvogen, Inc.	NDA	Current
47781-205	Estradiol Transdermal System	Estradiol	Alvogen, Inc.	NDA	Current
47781-206	Estradiol Transdermal System	Estradiol	Alvogen, Inc.	NDA	Current
47781-206	Estradiol Transdermal System	Estradiol	Alvogen, Inc.	NDA	Current
47781-207	Estradiol Transdermal System	Estradiol	Alvogen, Inc.	NDA	Current
47781-207	Estradiol Transdermal System	Estradiol	Alvogen, Inc.	NDA	Current
47781-208	Estradiol Transdermal System	Estradiol	Alvogen, Inc.	NDA	Current
47781-208	Estradiol Transdermal System	Estradiol	Alvogen, Inc.	NDA	Current
47781-209	Estradiol Transdermal System	Estradiol	Alvogen, Inc.	NDA	Current
47781-209	Estradiol Transdermal System	Estradiol	Alvogen, Inc.	NDA	Current
50419-451	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-451	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-451	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-451	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-451	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-451	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-452	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-452	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-452	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-452	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-452	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-452	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-453	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-453	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-453	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-453	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-453	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-453	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-454	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-454	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-454	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-454	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-454	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-454	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-455	Menostar	estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-455	Menostar	estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-455	Menostar	estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-455	Menostar	estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-455	Menostar	estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-455	Menostar	estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-456	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-456	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-456	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-456	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-456	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-456	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-459	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-459	Climara	Estradiol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77534	SUPPL	2024-02-16
77533	SUPPL	2024-02-16
77516	SUPPL	2024-02-16
77515	SUPPL	2024-02-16
68950	SUPPL	2021-10-08
68949	SUPPL	2021-10-08
68872	SUPPL	2021-10-05
68871	SUPPL	2021-10-05
68861	SUPPL	2021-10-01
68860	SUPPL	2021-10-01
68653	SUPPL	2021-09-20
68652	SUPPL	2021-09-20
50315	SUPPL	2017-11-06
50301	SUPPL	2017-11-06
50278	SUPPL	2017-11-02
50265	SUPPL	2017-11-02
24861	SUPPL	2013-10-31
34572	SUPPL	2013-10-17
2414	SUPPL	2013-10-11
2413	SUPPL	2008-01-09
34571	SUPPL	2008-01-08
24860	SUPPL	2006-01-06
12501	SUPPL	2006-01-05
12500	SUPPL	2005-06-24
2412	SUPPL	2005-06-24
2411	SUPPL	2005-03-23
41312	SUPPL	2004-09-21
12499	SUPPL	2004-02-12
2410	SUPPL	2004-02-02
41307	SUPPL	2003-08-08
41306	SUPPL	2003-08-08
41305	SUPPL	2003-08-08
41304	SUPPL	2003-08-08
20615	SUPPL	2003-08-08
20614	SUPPL	2003-08-08
41309	SUPPL	2003-05-22
41310	SUPPL	2003-05-15
41308	SUPPL	2003-05-15
34570	SUPPL	2003-04-24
34569	SUPPL	2001-04-11
2408	SUPPL	2001-04-11
2409	SUPPL	2001-04-05
41311	SUPPL	1999-05-20
20617	SUPPL	1999-03-05
12498	SUPPL	1999-03-05
2407	SUPPL	1999-03-05
20616	SUPPL	1998-03-23
12497	SUPPL	1998-03-23
2406	SUPPL	1998-03-23

Application 020375

Related Records#

Application Products#

NDC Listings For This Application#

Documents#