Application 084500
- Type
- ANDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESTRACE | ESTRADIOL | TABLET;ORAL | 2MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A084500-001 | ESTRACE | ESTRADIOL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A084500-001 | ESTRACE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 18505 | SUPPL | 2009-08-14 |