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| A081295-001 | ESTRACE | ESTRADIOL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1993-06-30 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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| 2026-07 | A081295-001 | ESTRACE | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1993-06-30 | caaa826d4ba7… | ||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… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A081295-001 | ESTRACE | 0.5MG | TABLET / ORAL | 1993-06-30 | e64feba35796… |
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 VAGINAL | ESTRADIOL | Redpharm Drug | 58beabb8-6902-b26a-e063-6294a90a67f8 | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Minivelle | ESTRADIOL | Noven Therapeutics, LLC | 6c5c47ab-28ee-11e1-bfc2-0800200c9a66 | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Redpharm Drug | 5718f042-e8c0-b721-e063-6294a90a5bef | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | A-S Medication Solutions | 5c9a2e0f-704b-4d16-8ea3-d94f7f36ce6b | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol Vaginal | ESTRADIOL | Redpharm Drug | 546c168d-2a85-69b6-e063-6294a90a22ac | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | e6bf2abc-71ae-4e79-a37b-164c98ba746a | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | A-S Medication Solutions | 34bcec8e-c7a6-4a1c-9884-4d4efe024bb9 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | REMEDYREPACK INC. | 41f7a56c-4ce3-4cc6-803e-1ff662efef90 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | REMEDYREPACK INC. | 59a4b68d-a507-4809-a0c8-fd9799986d12 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | A-S Medication Solutions | ba935918-39b3-4b56-bd83-78a29958e6d8 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | A-S Medication Solutions | 1c38f0d0-a360-4b66-bc0e-7d54e92465a1 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | REMEDYREPACK INC. | 477cb52e-8ce2-491f-94a0-869ff60bf7ab | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | A-S Medication Solutions | eacafc4a-2fa8-403d-8df7-2bc92d73a54f | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | A-S Medication Solutions | ee5460ab-27e7-487a-a89c-bf8735399be6 | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | REMEDYREPACK INC. | 774ee81b-8e29-46af-ab12-7157f63b443b | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| EstroGel | ESTRADIOL | ASCEND Therapeutics US, LLC | 762ac371-bb8b-47e7-b48f-e80d452c9dd4 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | A-S Medication Solutions | afd70875-0a93-40a7-842e-f4359818c2d9 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| 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 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 18497 | SUPPL | 2009-08-14 |