Application 084499

Type: ANDA
Sponsor: BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESTRACE	ESTRADIOL	TABLET;ORAL	1MG	No	No

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
A084499-001	ESTRACE	ESTRADIOL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A084499-001	ESTRACE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084499-001	ESTRACE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084499-001	ESTRACE	1MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084499-001	ESTRACE	1MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084499-001	ESTRACE	1MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084499-001	ESTRACE	1MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084499-001	ESTRACE	1MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084499-001	ESTRACE	1MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084499-001	ESTRACE	1MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084499-001	ESTRACE	1MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084499-001	ESTRACE	1MG	TABLET / ORAL	RLD, Approved before 1982	`f41ea6bd6efb…`

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 6 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOTTI	ESTRADIOL	Bryant Ranch Prepack	99b889a0-6200-4727-97d3-f5a0b7814e1b	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Bryant Ranch Prepack	9eb88585-4994-474f-bd63-c4e003bf6f20	2024-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Bryant Ranch Prepack	7eb1b2c3-8ece-47c3-96c0-606f7f5b5a32	2024-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Bryant Ranch Prepack	d9514497-6b9e-4c13-950b-6b036ff101c1	2024-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	NuCare Pharmaceuticals,Inc.	1bbdb10b-9a32-3899-e063-6294a90ab26d	2024-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	NuCare Pharmaceuticals,Inc.	7093dbe4-b096-2ddb-e053-2991aa0a1bb8	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRACE	ESTRADIOL	Allergan, Inc.	dfc41fcd-c5ba-4b25-b647-cf04d3988b3e	2024-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRACE generic name: ESTRADIOL
Estradiol	ESTRADIOL	Amneal Pharmaceuticals NY LLC	d4259bb8-91f8-4587-8ceb-35d44145aec0	2024-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
LYLLANA	ESTRADIOL	Amneal Pharmaceuticals LLC	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	2024-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Amneal Pharmaceuticals NY LLC	0500ee9b-bf4a-4432-9afe-20a7d60a6fe5	2024-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
DOTTI	ESTRADIOL	Amneal Pharmaceuticals LLC	53016d30-6b5f-49da-ac16-85ef415a5805	2024-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Bryant Ranch Prepack	0e927450-3f02-4d2f-9235-a255357e8d93	2024-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Bryant Ranch Prepack	6a4e82a4-d980-4c04-9e33-9444a292728a	2024-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Bryant Ranch Prepack	eab9a629-b3d4-4faf-bce4-656fe3b46d38	2024-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	ANI Pharmaceuticals, Inc.	3fe899db-a8cd-4a31-88fb-1129be96b4d9	2024-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Noven Therapeutics, LLC	bf185599-2138-4083-9c52-2b95dce09ae0	2024-04-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Bryant Ranch Prepack	80d6644a-d6f2-48e7-a685-92c4255b19fe	2024-04-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Bryant Ranch Prepack	414b846a-d6d9-4e8a-9632-12e296fc13c3	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
YUVAFEM	ESTRADIOL	Amneal Pharmaceuticals LLC	30c7f6ba-7a9e-4853-b3e4-e00a46560224	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Amneal Pharmaceuticals of New York LLC	094830ee-1b1c-4cf7-8a39-427dfd56f9c9	2024-04-03	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
18504	SUPPL	2009-08-14