Application 217334
- Type
- ANDA
- Sponsor
- NOVITIUM PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESTRADIOL | ESTRADIOL | TABLET;ORAL | 0.5MG | No | No |
| 002 | ESTRADIOL | ESTRADIOL | TABLET;ORAL | 1MG | No | No |
| 003 | ESTRADIOL | ESTRADIOL | TABLET;ORAL | 2MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217334-001 | ESTRADIOL | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 2023-09-06 | |
| A217334-002 | ESTRADIOL | ESTRADIOL | 1MG | TABLET / ORAL | AB | 2023-09-06 | |
| A217334-003 | ESTRADIOL | ESTRADIOL | 2MG | TABLET / ORAL | AB | 2023-09-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217334-001 | AB |
| A217334-002 | AB |
| A217334-003 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217334-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 2023-09-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217334-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 2023-09-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217334-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 2023-09-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217334-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 2023-09-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217334-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 2023-09-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217334-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 2023-09-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217334-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 2023-09-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217334-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 2023-09-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217334-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 2023-09-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217334-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 2023-09-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217334-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 2023-09-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217334-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 2023-09-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217334-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 2023-09-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217334-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 2023-09-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217334-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 2023-09-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217334-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 2023-09-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217334-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 2023-09-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217334-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 2023-09-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217334-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 2023-09-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217334-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 2023-09-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217334-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 2023-09-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217334-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 2023-09-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217334-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 2023-09-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217334-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 2023-09-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217334-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 2023-09-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217334-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 2023-09-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217334-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 2023-09-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217334-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 2023-09-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217334-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 2023-09-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217334-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 2023-09-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217334-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 2023-09-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217334-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 2023-09-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217334-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 2023-09-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217334-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 2023-09-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217334-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 2023-09-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217334-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 2023-09-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217334-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 2023-09-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217334-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 2023-09-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217334-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 2023-09-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A217334-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 2023-09-06 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217334-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217334-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217334-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217334-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217334-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217334-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217334-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217334-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217334-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217334-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217334-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217334-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217334-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217334-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217334-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217334-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217334-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217334-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217334-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217334-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217334-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217334-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217334-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217334-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217334-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217334-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217334-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A217334-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A217334-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A217334-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217334-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217334-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217334-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217334-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217334-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217334-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217334-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217334-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217334-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A217334-001 | AB | 1 | 8072bd15b7f6… |
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 | Redpharm Drug | 5718f042-e8c0-b721-e063-6294a90a5bef | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | REMEDYREPACK INC. | 41f7a56c-4ce3-4cc6-803e-1ff662efef90 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | REMEDYREPACK INC. | 59a4b68d-a507-4809-a0c8-fd9799986d12 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | Preferred Pharmaceuticals, Inc. | 6d129a94-8ecd-40a3-9a95-c5e1ece41ab1 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | Direct_Rx | 47e446f8-ac16-ea6b-e063-6394a90a1726 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | Northwind Health Company, LLC | 106b92da-334c-542f-e063-6394a90aa65b | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | Northwind Health Company, LLC | 0a1e744c-7926-0e0c-e063-6294a90a80d0 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | NorthStar Rx LLC | 1c2cd11a-e010-20b2-e063-6294a90a52d5 | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | ff3bcb07-f6fe-4582-948a-21dbf1e55f55 | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | Coupler LLC | 37c99e4d-fb0d-0e6e-e063-6394a90a69c8 | 2025-06-17 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | Preferred Pharmaceuticals Inc. | 72fbd5a8-9c34-4790-84ed-79f5bd3ae0f0 | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | PD-Rx Pharmaceuticals, Inc. | aa396e57-0a93-49cc-82e5-cd35c987bb0b | 2025-02-20 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | A-S Medication Solutions | f7e8dd35-c12f-46be-96f9-bf9a9b6f9a90 | 2024-12-30 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | A-S Medication Solutions | 41f424ec-9d08-4fda-b21d-41e92da6e1f0 | 2024-12-30 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | NuCare Pharmaceuticals,Inc. | 230c2eda-b0f1-d9ec-e063-6394a90a603c | 2024-09-26 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | 5e9bd73f-67db-44f9-a5ee-409eed765cd2 | 2024-09-03 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | 9eb88585-4994-474f-bd63-c4e003bf6f20 | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | NuCare Pharmaceuticals,Inc. | 1bbdb10b-9a32-3899-e063-6294a90ab26d | 2024-06-25 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |
| Estradiol | ESTRADIOL | ANI Pharmaceuticals, Inc. | 3fe899db-a8cd-4a31-88fb-1129be96b4d9 | 2024-04-15 | Boxed warning, Warnings, Adverse reactions | 217334 ANDA217334 |