Application 081295
- Type
- ANDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESTRACE | ESTRADIOL | TABLET;ORAL | 0.5MG | No | No |
Orange Book products#
| 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| A081295-001 | ESTRACE | ESTRADIOL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1993-06-30 |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.
| 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| 2026-08 | A081295-001 | ESTRACE | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1993-06-30 | 84e616aacf4f… | ||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| 2026-07 | A081295-001 | ESTRACE | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1993-06-30 | caaa826d4ba7… | ||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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ESTRADIOL | ESTRADIOL | Encube Ethicals, Inc. | 54f108d6-ddd2-4276-8508-2c8e16a65fb2 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol Gel | ESTRADIOL | Encube Ethicals, Inc. | d4a3606f-83b2-45df-bc77-faebfa796f9a | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estring | ESTRADIOL | Pfizer Laboratories Div Pfizer Inc | 110b9865-5a07-4d45-b560-e89947f12600 | 2026-04-23 | Warnings, Adverse reactions | ESTRADIOL |
| Estradiol Vaginal | ESTRADIOL | A-S Medication Solutions | 0137d491-6917-4060-9b32-e0cd7b0badbb | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Preferred Pharmaceuticals, Inc. | 6d129a94-8ecd-40a3-9a95-c5e1ece41ab1 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol Vaginal | ESTRADIOL | Bryant Ranch Prepack | 67f581cb-6d77-49fc-b2f3-976e3b57dcbf | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Climara | ESTRADIOL | Bayer HealthCare Pharmaceuticals Inc. | 1e9702c4-f2d7-4ea8-b6e8-7dca31671864 | 2026-03-26 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Menostar | ESTRADIOL | Bayer HealthCare Pharmaceuticals Inc. | a78708cd-04d4-4221-a4e4-53680bbe2912 | 2026-03-12 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol Transdermal System | ESTRADIOL | Sandoz Inc | c714974b-766f-42f2-a846-b0c1f5a60560 | 2026-03-04 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | Padagis Israel Pharmaceuticals Ltd | 3ac905b3-904c-4285-97ed-e787d006c7dd | 2026-02-28 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| DIVIGEL | ESTRADIOL | Vertical Pharmaceuticals, LLC | 59e610dc-883e-4f07-9ec6-a5841b0bf9fb | 2026-02-27 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Mylan Pharmaceuticals Inc. | 98770987-b313-4f2a-9aac-db0ab2068cc6 | 2026-02-15 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | REMEDYREPACK INC. | 170ec388-d399-4543-8743-208394b38904 | 2026-02-13 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Solaris Pharma Corporation | 67e8665c-5331-423c-99fd-546ab6cccb07 | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Yuvafem | ESTRADIOL | AvKARE | d20abc9a-8f47-e274-c9b1-b71c9489761f | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol Vaginal | ESTRADIOL | AvKARE | bb7b442d-b8c3-b7f0-e053-2a95a90a2c94 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol 1557 | ESTRADIOL | Professional Complementary Health Formulas | f0da282a-6c7e-4a18-870f-d0d8efc2c7e9 | 2026-01-08 | Warnings | ESTRADIOL |
| Estradiol | ESTRADIOL | Direct_Rx | 47e446f8-ac16-ea6b-e063-6394a90a1726 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Northwind Health Company, LLC | 106b92da-334c-542f-e063-6394a90aa65b | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Northwind Health Company, LLC | 0a1e744c-7926-0e0c-e063-6294a90a80d0 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 18497 | SUPPL | 2009-08-14 |