Application 081295

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	0.5MG	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
A081295-001	ESTRACE	ESTRADIOL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1993-06-30

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A081295-001	ESTRACE	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1993-06-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A081295-001	ESTRACE	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1993-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A081295-001	ESTRACE	0.5MG	TABLET / ORAL	1993-06-30	`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 5 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ESTRADIOL	ESTRADIOL	A-S Medication Solutions	376beb31-5fed-4aae-a16f-71a7d243d5eb	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol Vaginal	ESTRADIOL	A-S Medication Solutions	e5dbfeff-188f-4991-b2b7-f5f03987f7fb	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	PURACAP LABORATORIES, LLC	97ace322-341a-4d52-8c63-17265ed9aa8d	2025-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	EPIC PHARMA, LLC	9333d92f-2585-4b99-aaea-87c01c95125e	2025-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	f7e8dd35-c12f-46be-96f9-bf9a9b6f9a90	2024-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	41f424ec-9d08-4fda-b21d-41e92da6e1f0	2024-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Evamist	ESTRADIOL	Padagis US LLC	9a0aa631-133d-406b-9d32-8a1a99af4e50	2024-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	ANI Pharmaceuticals, Inc.	3518120e-cc44-4d70-8a20-0ef2dce9a3c6	2024-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Proficient Rx LP	7e570b07-2a9e-49bf-b224-1e34f6eda3ab	2024-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	NuCare Pharmaceuticals,Inc.	230c2eda-b0f1-d9ec-e063-6394a90a603c	2024-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Bryant Ranch Prepack	5e9bd73f-67db-44f9-a5ee-409eed765cd2	2024-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Bryant Ranch Prepack	74baff07-15df-48a8-93b8-3a317f896a56	2024-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
DOTTI	ESTRADIOL	Bryant Ranch Prepack	75fc6d3a-49b6-47ad-b704-410692010d3a	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
DOTTI	ESTRADIOL	Bryant Ranch Prepack	b119df4a-c514-4804-b1a8-b09c6058e80d	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
DOTTI	ESTRADIOL	Bryant Ranch Prepack	f419192a-eb95-4087-9fe0-0eea639ef51b	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRACE	ESTRADIOL	A-S Medication Solutions	da52a602-f2a2-4382-be07-30351c58cc4b	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRACE generic name: ESTRADIOL
DOTTI	ESTRADIOL	Bryant Ranch Prepack	779751dc-243a-4dc2-ae67-3669f196b205	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol Vaginal	ESTRADIOL	Bryant Ranch Prepack	e7b15ec3-e195-44a6-bdd7-9b6de2b235b8	2024-07-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	7f3c96ce-c855-4372-95ba-7759dd82bcca	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	NuCare Pharmaceuticals, Inc.	5423c0da-eb10-20cd-e054-00144ff8d46c	2024-07-17	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
18497	SUPPL	2009-08-14