Application 040275
- Type
- ANDA
- Sponsor
- EPIC PHARMA INC
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 |
|---|---|---|---|---|---|---|---|
| A040275-001 | ESTRADIOL | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | |
| A040275-002 | ESTRADIOL | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | |
| A040275-003 | ESTRADIOL | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040275-001 | AB |
| A040275-002 | AB |
| A040275-003 | 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 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 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 | A040275-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040275-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040275-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040275-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040275-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040275-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040275-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040275-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040275-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040275-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040275-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040275-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040275-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040275-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040275-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040275-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040275-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040275-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040275-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040275-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040275-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040275-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040275-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040275-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040275-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040275-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040275-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040275-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040275-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040275-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040275-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040275-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040275-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040275-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040275-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040275-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040275-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040275-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040275-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040275-001 | 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 | A-S Medication Solutions | 5c9a2e0f-704b-4d16-8ea3-d94f7f36ce6b | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | REMEDYREPACK INC. | 477cb52e-8ce2-491f-94a0-869ff60bf7ab | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | A-S Medication Solutions | afd70875-0a93-40a7-842e-f4359818c2d9 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | REMEDYREPACK INC. | 170ec388-d399-4543-8743-208394b38904 | 2026-02-13 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 70518-2829 |
| ESTRADIOL | ESTRADIOL | Northwind Health Company, LLC | f76aff99-f415-9045-e053-6294a90afd51 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | Preferred Pharmaceuticals Inc. | 9956a196-fefd-4766-a225-e154fbd3aeff | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 68788-7102 |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | fad3813c-9495-416b-9789-623d5758b4e3 | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 71335-0226 |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | cf1ebc1d-8f3c-4468-b565-f0da69986e7c | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 71335-0797 |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | bfc1beb9-1ade-446e-97dd-55b41c2fa851 | 2025-03-25 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 63629-4788 |
| ESTRADIOL | ESTRADIOL | A-S Medication Solutions | 8788ddd1-36a6-416a-b527-75eb41de2808 | 2025-02-18 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | 487ce40e-1f13-4497-994a-c5d91b87b6cc | 2025-02-13 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 76420-023 76420-022 76420-021 |
| Estradiol | ESTRADIOL | Direct_Rx | 032135ee-7bc9-5cdf-e063-6394a90ad9a2 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| Estradiol | ESTRADIOL | Direct_Rx | 01789bad-4be4-ae22-e063-6294a90af392 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | A-S Medication Solutions | 376beb31-5fed-4aae-a16f-71a7d243d5eb | 2025-01-09 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 50090-5494 |
| ESTRADIOL | ESTRADIOL | PURACAP LABORATORIES, LLC | 97ace322-341a-4d52-8c63-17265ed9aa8d | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 24658-702 24658-704 24658-703 |
| ESTRADIOL | ESTRADIOL | EPIC PHARMA, LLC | 9333d92f-2585-4b99-aaea-87c01c95125e | 2025-01-07 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 42806-088 42806-087 42806-089 |
| ESTRADIOL | ESTRADIOL | NuCare Pharmaceuticals, Inc. | 5423c0da-eb10-20cd-e054-00144ff8d46c | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 68071-3394 |
| ESTRADIOL | ESTRADIOL | NuCare Pharmaceuticals,Inc. | 7093dbe4-b096-2ddb-e053-2991aa0a1bb8 | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 68071-4485 |
| ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | 229b4ec5-d3c8-4406-9fc5-8f633c6447b8 | 2022-10-12 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 76420-023 76420-022 76420-021 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17856-0089 | ESTRADIOL | ESTRADIOL | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 23155-013 | Estradiol | Estradiol | Heritage Pharmaceuticals Inc | ANDA | Current |
| 23155-014 | Estradiol | Estradiol | Heritage Pharmaceuticals Inc | ANDA | Current |
| 23155-015 | Estradiol | Estradiol | Heritage Pharmaceuticals Inc | ANDA | Current |
| 24658-702 | ESTRADIOL | ESTRADIOL | PURACAP LABORATORIES, LLC | ANDA | Current |
| 24658-703 | ESTRADIOL | ESTRADIOL | PURACAP LABORATORIES, LLC | ANDA | Current |
| 24658-704 | ESTRADIOL | ESTRADIOL | PURACAP LABORATORIES, LLC | ANDA | Current |
| 42806-087 | ESTRADIOL | ESTRADIOL | EPIC PHARMA, LLC | ANDA | Current |
| 42806-087 | ESTRADIOL | ESTRADIOL | EPIC PHARMA, LLC | ANDA | Current |
| 42806-087 | ESTRADIOL | ESTRADIOL | EPIC PHARMA, LLC | ANDA | Current |
| 42806-088 | ESTRADIOL | ESTRADIOL | EPIC PHARMA, LLC | ANDA | Current |
| 42806-088 | ESTRADIOL | ESTRADIOL | EPIC PHARMA, LLC | ANDA | Current |
| 42806-088 | ESTRADIOL | ESTRADIOL | EPIC PHARMA, LLC | ANDA | Current |
| 42806-089 | ESTRADIOL | ESTRADIOL | EPIC PHARMA, LLC | ANDA | Current |
| 42806-089 | ESTRADIOL | ESTRADIOL | EPIC PHARMA, LLC | ANDA | Current |
| 42806-089 | ESTRADIOL | ESTRADIOL | EPIC PHARMA, LLC | ANDA | Current |
| 50090-5494 | ESTRADIOL | ESTRADIOL | A-S Medication Solutions | ANDA | Current |
| 50090-5494 | ESTRADIOL | ESTRADIOL | A-S Medication Solutions | ANDA | Current |
| 63629-4788 | ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | ANDA | Current |
| 63629-4788 | ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | ANDA | Current |
| 63629-8053 | ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | ANDA | Current |
| 68071-3394 | ESTRADIOL | ESTRADIOL | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3394 | ESTRADIOL | ESTRADIOL | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3394 | ESTRADIOL | ESTRADIOL | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4485 | ESTRADIOL | ESTRADIOL | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7102 | ESTRADIOL | ESTRADIOL | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7102 | ESTRADIOL | ESTRADIOL | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7102 | ESTRADIOL | ESTRADIOL | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7102 | ESTRADIOL | ESTRADIOL | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7102 | ESTRADIOL | ESTRADIOL | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7332 | ESTRADIOL | ESTRADIOL | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7332 | ESTRADIOL | ESTRADIOL | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7332 | ESTRADIOL | ESTRADIOL | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7332 | ESTRADIOL | ESTRADIOL | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7567 | ESTRADIOL | ESTRADIOL | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7567 | ESTRADIOL | ESTRADIOL | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-2829 | ESTRADIOL | ESTRADIOL | REMEDYREPACK INC. | ANDA | Current |
| 70518-2829 | ESTRADIOL | ESTRADIOL | REMEDYREPACK INC. | ANDA | Current |
| 70934-798 | ESTRADIOL | ESTRADIOL | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71335-0226 | ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | ANDA | Current |
| 71335-0226 | ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | ANDA | Current |
| 71335-0226 | ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | ANDA | Current |
| 71335-0797 | ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | ANDA | Current |
| 71335-0797 | ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | ANDA | Current |
| 71335-0797 | ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | ANDA | Current |
| 76420-021 | ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | ANDA | Current |
| 76420-021 | ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | ANDA | Current |
| 76420-021 | ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | ANDA | Current |
| 76420-021 | ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | ANDA | Current |
| 76420-022 | ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | ANDA | Current |
| 76420-022 | ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | ANDA | Current |
| 76420-022 | ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | ANDA | Current |
| 76420-022 | ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | ANDA | Current |
| 76420-023 | ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | ANDA | Current |
| 76420-023 | ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | ANDA | Current |
| 76420-023 | ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | ANDA | Current |
| 76420-023 | ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | ANDA | Current |