Application 040197
- Type
- ANDA
- Sponsor
- BARR LABS 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 | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040197-001 | ESTRADIOL | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | |
| A040197-002 | ESTRADIOL | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | |
| A040197-003 | ESTRADIOL | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040197-001 | AB |
| A040197-002 | AB |
| A040197-003 | 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 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 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 | A040197-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040197-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040197-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040197-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040197-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040197-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040197-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040197-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040197-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040197-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040197-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040197-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040197-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040197-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040197-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040197-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040197-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040197-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040197-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040197-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040197-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040197-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040197-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040197-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040197-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040197-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040197-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040197-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040197-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040197-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040197-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040197-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040197-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040197-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040197-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040197-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040197-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040197-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040197-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040197-001 | 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 | REMEDYREPACK INC. | 774ee81b-8e29-46af-ab12-7157f63b443b | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | Northwind Health Company, LLC | f6caf47a-1917-c493-e053-6394a90af63e | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | Northwind Health Company, LLC | f6cb38ab-fdff-9c07-e053-6294a90ad59a | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | PD-Rx Pharmaceuticals, Inc. | f3a77482-f490-f350-e053-2a95a90ad8cb | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | NuCare Pharmaceuticals,Inc. | c8ac2e13-58d5-4e70-e053-2995a90aff04 | 2025-09-22 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | American Health Packaging | 265a1ee1-f314-4324-a2e1-0120a9a00a20 | 2025-05-02 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | A-S Medication Solutions | 3e84e3e7-4b50-407f-a215-45363b541384 | 2025-04-15 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 50090-1882 50090-1876 50090-1704 |
| Estradiol | ESTRADIOL | PD-Rx Pharmaceuticals, Inc. | d0d1c2c8-b175-4250-9343-d7db65b72e8f | 2025-03-13 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | NuCare Pharmaceuticals,Inc. | dd7d2d2a-e76b-7dfe-e053-2995a90a790a | 2025-02-26 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | PharmPak, Inc. | 20b50139-4e13-4f0c-aaf5-ecb83911d9e6 | 2025-01-16 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 54348-701 |
| Estradiol | ESTRADIOL | Proficient Rx LP | 7e570b07-2a9e-49bf-b224-1e34f6eda3ab | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 63187-741 |
| Estradiol | ESTRADIOL | A-S Medication Solutions | 7f3c96ce-c855-4372-95ba-7759dd82bcca | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | 80d6644a-d6f2-48e7-a685-92c4255b19fe | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | 414b846a-d6d9-4e8a-9632-12e296fc13c3 | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | Teva Pharmaceuticals USA, Inc. | c4936878-1643-4e7f-9b0d-e4957935aef2 | 2024-02-01 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 0555-0899 0555-0887 0555-0886 |
| Estradiol | ESTRADIOL | PharmPak, Inc. | 8f8c5a0b-4d7b-a5cb-e053-2995a90a494e | 2022-10-09 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 54348-702 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0179-1999 | Estradiol | Estradiol | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0430-0720 | Estrace | Estradiol | Allergan, Inc. | ANDA | Current |
| 0430-0720 | Estrace | Estradiol | Allergan, Inc. | ANDA | Current |
| 0430-0720 | Estrace | Estradiol | Allergan, Inc. | ANDA | Current |
| 0430-0720 | Estrace | Estradiol | Allergan, Inc. | ANDA | Current |
| 0430-0721 | Estrace | Estradiol | Allergan, Inc. | ANDA | Current |
| 0430-0721 | Estrace | Estradiol | Allergan, Inc. | ANDA | Current |
| 0430-0721 | Estrace | Estradiol | Allergan, Inc. | ANDA | Current |
| 0430-0721 | Estrace | Estradiol | Allergan, Inc. | ANDA | Current |
| 0430-0722 | Estrace | Estradiol | Allergan, Inc. | ANDA | Current |
| 0430-0722 | Estrace | Estradiol | Allergan, Inc. | ANDA | Current |
| 0430-0722 | Estrace | Estradiol | Allergan, Inc. | ANDA | Current |
| 0430-0722 | Estrace | Estradiol | Allergan, Inc. | ANDA | Current |
| 0555-0886 | Estradiol | Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0886 | Estradiol | Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0886 | Estradiol | Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0886 | Estradiol | Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0886 | Estradiol | Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0887 | Estradiol | Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0887 | Estradiol | Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0887 | Estradiol | Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0887 | Estradiol | Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0887 | Estradiol | Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0899 | Estradiol | Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0899 | Estradiol | Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0899 | Estradiol | Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0899 | Estradiol | Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0899 | Estradiol | Estradiol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 33261-667 | Estradiol | Estradiol | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-714 | Estradiol | Estradiol | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 43063-706 | Estradiol | Estradiol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-706 | Estradiol | Estradiol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-706 | Estradiol | Estradiol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-706 | Estradiol | Estradiol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-706 | Estradiol | Estradiol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-717 | Estradiol | Estradiol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-717 | Estradiol | Estradiol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-717 | Estradiol | Estradiol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-717 | Estradiol | Estradiol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-717 | Estradiol | Estradiol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-1704 | Estradiol | Estradiol | A-S Medication Solutions | ANDA | Current |
| 50090-1704 | Estradiol | Estradiol | A-S Medication Solutions | ANDA | Current |
| 50090-1704 | Estradiol | Estradiol | A-S Medication Solutions | ANDA | Current |
| 50090-1876 | Estradiol | Estradiol | A-S Medication Solutions | ANDA | Current |
| 50090-1876 | Estradiol | Estradiol | A-S Medication Solutions | ANDA | Current |
| 50090-1882 | Estradiol | Estradiol | A-S Medication Solutions | ANDA | Current |
| 50090-1882 | Estradiol | Estradiol | A-S Medication Solutions | ANDA | Current |
| 51862-332 | Estradiol | Estradiol | Mayne Pharma Inc. | ANDA | Current |
| 51862-332 | Estradiol | Estradiol | Mayne Pharma Inc. | ANDA | Current |
| 51862-332 | Estradiol | Estradiol | Mayne Pharma Inc. | ANDA | Current |
| 51862-333 | Estradiol | Estradiol | Mayne Pharma Inc. | ANDA | Current |
| 51862-333 | Estradiol | Estradiol | Mayne Pharma Inc. | ANDA | Current |
| 51862-333 | Estradiol | Estradiol | Mayne Pharma Inc. | ANDA | Current |
| 51862-334 | Estradiol | Estradiol | Mayne Pharma Inc. | ANDA | Current |
| 51862-334 | Estradiol | Estradiol | Mayne Pharma Inc. | ANDA | Current |
| 51862-334 | Estradiol | Estradiol | Mayne Pharma Inc. | ANDA | Current |
| 54348-701 | Estradiol | ESTRADIOL | PharmPak, Inc. | ANDA | Current |
| 54348-701 | Estradiol | ESTRADIOL | PharmPak, Inc. | ANDA | Current |
| 54348-702 | Estradiol | ESTRADIOL | PharmPak, Inc. | ANDA | Current |
| 54348-702 | Estradiol | ESTRADIOL | PharmPak, Inc. | ANDA | Current |
| 55700-458 | Estradiol | Estradiol | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-504 | Estradiol | Estradiol | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60429-833 | Estradiol | Estradiol | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-833 | Estradiol | Estradiol | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-833 | Estradiol | Estradiol | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-833 | Estradiol | Estradiol | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-834 | Estradiol | Estradiol | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-834 | Estradiol | Estradiol | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-834 | Estradiol | Estradiol | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-834 | Estradiol | Estradiol | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-835 | Estradiol | Estradiol | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-835 | Estradiol | Estradiol | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-835 | Estradiol | Estradiol | Golden State Medical Supply, Inc. | ANDA | Current |
| 61919-194 | ESTRADIOL | ESTRADIOL | DirectRX | ANDA | Current |
| 61919-195 | ESTRADIOL | ESTRADIOL | Direct_Rx | ANDA | Current |
| 61919-198 | ESTRADIOL | ESTRADIOL | DirectRX | ANDA | Current |
| 61919-198 | ESTRADIOL | ESTRADIOL | Direct_Rx | ANDA | Current |
| 61919-198 | ESTRADIOL | ESTRADIOL | Direct_Rx | ANDA | Current |
| 61919-278 | ESTRADIOL | ESTRADIOL | Direct_Rx | ANDA | Current |
| 63187-741 | Estradiol | Estradiol | Proficient Rx LP | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 42593 | ORIG | 2011-03-10 |