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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020375-001	CLIMARA	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1994-12-22
N020375-002	CLIMARA	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD, RS	1994-12-22
N020375-003	CLIMARA	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1998-03-23
N020375-004	CLIMARA	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1999-03-05
N020375-005	CLIMARA	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27
N020375-006	CLIMARA	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N020375-001	AB2
N020375-002	AB2
N020375-003	AB2
N020375-004	AB2
N020375-005	AB2
N020375-006	AB2

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020375-001	CLIMARA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1994-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-002	CLIMARA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD, RS	1994-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-003	CLIMARA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1998-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-004	CLIMARA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1999-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-005	CLIMARA	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-006	CLIMARA	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-001	CLIMARA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1994-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-002	CLIMARA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD, RS	1994-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-003	CLIMARA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1998-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-004	CLIMARA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1999-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-005	CLIMARA	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-006	CLIMARA	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020375-001	CLIMARA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1994-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-002	CLIMARA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD, RS	1994-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-003	CLIMARA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1998-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-004	CLIMARA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1999-03-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-005	CLIMARA	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-006	CLIMARA	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-001	CLIMARA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1994-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-002	CLIMARA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD, RS	1994-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-003	CLIMARA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1998-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-004	CLIMARA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1999-03-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-005	CLIMARA	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-006	CLIMARA	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-001	CLIMARA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1994-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-002	CLIMARA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD, RS	1994-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-003	CLIMARA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1998-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-004	CLIMARA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1999-03-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-005	CLIMARA	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-006	CLIMARA	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-001	CLIMARA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1994-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-002	CLIMARA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD, RS	1994-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-003	CLIMARA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1998-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-004	CLIMARA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1999-03-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-005	CLIMARA	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-006	CLIMARA	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020375-001	CLIMARA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1994-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020375-002	CLIMARA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD, RS	1994-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020375-003	CLIMARA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1998-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020375-004	CLIMARA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1999-03-05	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020375-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-005	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-006	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-005	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-006	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020375-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-005	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-006	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-004	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-005	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-006	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-004	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-005	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-006	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-004	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-005	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-006	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020375-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020375-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020375-003	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020375-004	AB2	1	`2680178bc6a6…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Climara	ESTRADIOL	Bayer HealthCare Pharmaceuticals Inc.	1e9702c4-f2d7-4ea8-b6e8-7dca31671864	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020375 application number: NDA020375 ndc (product): 50419-459
Menostar	ESTRADIOL	Bayer HealthCare Pharmaceuticals Inc.	a78708cd-04d4-4221-a4e4-53680bbe2912	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020375 application number: NDA020375
Estradiol Transdermal System	ESTRADIOL	Sandoz Inc	c714974b-766f-42f2-a846-b0c1f5a60560	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020375 application number: NDA020375

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 84 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50419-459	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
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