Application 021674

Type: NDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MENOSTAR	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.014MG/24HR	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021674-001	MENOSTAR	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021674-001	AB

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 2 · 43 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
2026-09-14 22:38:34	2026-08	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL		RLD, RS	2004-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL		RLD, RS	2004-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL		RLD, RS	2004-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021674-001	MENOSTAR	0.014MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RLD, RS	2004-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL		RLD, RS	2004-06-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL		RLD, RS	2004-06-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL		RLD, RS	2004-06-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL		RLD, RS	2004-06-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021674-001	MENOSTAR	0.014MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RLD, RS	2004-06-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021674-001	MENOSTAR	0.014MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RLD, RS	2004-06-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021674-001	MENOSTAR	0.014MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RLD, RS	2004-06-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021674-001	MENOSTAR	0.014MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RLD, RS	2004-06-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021674-001	MENOSTAR	0.014MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RLD, RS	2004-06-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	2004-06-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL		RLD, RS	2004-06-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL		RLD, RS	2004-06-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL		RLD, RS	2004-06-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021674-001	MENOSTAR	0.014MG/24HR	SYSTEM / TRANSDERMAL		RLD, RS	2004-06-08	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021674-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021674-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021674-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021674-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021674-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021674-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021674-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021674-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021674-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021674-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021674-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021674-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021674-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021674-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021674-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021674-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021674-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021674-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021674-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021674-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021674-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021674-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021674-001	AB	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021674-001	AB	1	`a50c72e98297…`

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 7 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	8cb31c7c-fba8-4201-833d-844ea1a8a4de	2024-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	684850eb-d889-4370-a0a7-4a5c3113266a	2024-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	db4696da-7820-4b2b-97b4-fb05b1208020	2024-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	839fe7ae-6835-4d6a-b6b1-ca7f062caa4f	2024-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Sandoz Inc	c4da6de7-9ab1-4fcf-88f3-fe785019e6e7	2024-02-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	c4936878-1643-4e7f-9b0d-e4957935aef2	2024-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ELESTRIN	ESTRADIOL	Viatris Specialty LLC	eff2dea1-f117-11e3-ac10-0800200c9a66	2023-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	31646359-292c-4bca-88a4-7a89b11c3f44	2023-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Vivelle-Dot	ESTRADIOL	Sandoz Inc	5ccb77f9-d47b-4381-ad5c-5b92524e1c4a	2023-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estrogen 4X	ESTRADIOL	Nutritional Specialties, Inc.	772c2a8a-10e2-49af-8db6-4d5ca64b1719	2023-07-25	Warnings	Name fallback generic name: ESTRADIOL
estradiol	ESTRADIOL	Zydus Lifesciences Limited	2f2030c2-f72e-4142-9cff-540bc8fbf8a1	2023-04-21		Name fallback generic name: ESTRADIOL
estradiol	ESTRADIOL	Zydus Lifesciences Limited	8b672c79-0896-4d6e-b225-299e89068ad7	2023-04-21		Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Zydus Lifesciences Limited	b79fd5ea-962f-491c-b670-40efe42ccf79	2022-12-07		Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Asclemed USA, Inc.	229b4ec5-d3c8-4406-9fc5-8f633c6447b8	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	PharmPak, Inc.	8f8c5a0b-4d7b-a5cb-e053-2995a90a494e	2022-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24006	ORIG	2015-10-06
21776	ORIG	2006-01-03
15958	ORIG	2004-06-10
5960	ORIG	2004-06-10