Application 020323
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIVELLE | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.0375MG/24HR | No | No |
| 002 | VIVELLE | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.05MG/24HR | No | No |
| 003 | VIVELLE | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.075MG/24HR | No | No |
| 004 | VIVELLE | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.1MG/24HR | No | No |
| 005 | VIVELLE | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.025MG/24HR | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020323-001 | VIVELLE | ESTRADIOL | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | ||
| N020323-002 | VIVELLE | ESTRADIOL | 0.05MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | ||
| N020323-003 | VIVELLE | ESTRADIOL | 0.075MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | ||
| N020323-004 | VIVELLE | ESTRADIOL | 0.1MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | ||
| N020323-005 | VIVELLE | ESTRADIOL | 0.025MG/24HR | SYSTEM / TRANSDERMAL | 2000-08-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020323-001 | VIVELLE | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020323-002 | VIVELLE | 0.05MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020323-003 | VIVELLE | 0.075MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020323-004 | VIVELLE | 0.1MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020323-005 | VIVELLE | 0.025MG/24HR | SYSTEM / TRANSDERMAL | 2000-08-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020323-001 | VIVELLE | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020323-002 | VIVELLE | 0.05MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020323-003 | VIVELLE | 0.075MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020323-004 | VIVELLE | 0.1MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020323-005 | VIVELLE | 0.025MG/24HR | SYSTEM / TRANSDERMAL | 2000-08-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020323-001 | VIVELLE | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020323-002 | VIVELLE | 0.05MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020323-003 | VIVELLE | 0.075MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020323-004 | VIVELLE | 0.1MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020323-005 | VIVELLE | 0.025MG/24HR | SYSTEM / TRANSDERMAL | 2000-08-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020323-001 | VIVELLE | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020323-002 | VIVELLE | 0.05MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020323-003 | VIVELLE | 0.075MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020323-004 | VIVELLE | 0.1MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020323-005 | VIVELLE | 0.025MG/24HR | SYSTEM / TRANSDERMAL | 2000-08-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020323-001 | VIVELLE | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020323-002 | VIVELLE | 0.05MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020323-003 | VIVELLE | 0.075MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020323-004 | VIVELLE | 0.1MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020323-005 | VIVELLE | 0.025MG/24HR | SYSTEM / TRANSDERMAL | 2000-08-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020323-001 | VIVELLE | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020323-002 | VIVELLE | 0.05MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020323-003 | VIVELLE | 0.075MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020323-004 | VIVELLE | 0.1MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020323-005 | VIVELLE | 0.025MG/24HR | SYSTEM / TRANSDERMAL | 2000-08-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020323-001 | VIVELLE | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020323-002 | VIVELLE | 0.05MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020323-003 | VIVELLE | 0.075MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020323-004 | VIVELLE | 0.1MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020323-005 | VIVELLE | 0.025MG/24HR | SYSTEM / TRANSDERMAL | 2000-08-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020323-001 | VIVELLE | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020323-002 | VIVELLE | 0.05MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020323-003 | VIVELLE | 0.075MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020323-004 | VIVELLE | 0.1MG/24HR | SYSTEM / TRANSDERMAL | 1994-10-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020323-005 | VIVELLE | 0.025MG/24HR | SYSTEM / TRANSDERMAL | 2000-08-16 | 03ed91905a0d… |
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 | Teva Pharmaceuticals USA, Inc. | 8cb31c7c-fba8-4201-833d-844ea1a8a4de | 2024-04-01 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| estradiol | ESTRADIOL | Zydus Pharmaceuticals USA Inc. | 684850eb-d889-4370-a0a7-4a5c3113266a | 2024-03-20 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| estradiol | ESTRADIOL | Zydus Pharmaceuticals USA Inc. | db4696da-7820-4b2b-97b4-fb05b1208020 | 2024-03-20 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Zydus Pharmaceuticals USA Inc. | 839fe7ae-6835-4d6a-b6b1-ca7f062caa4f | 2024-03-15 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Sandoz Inc | c4da6de7-9ab1-4fcf-88f3-fe785019e6e7 | 2024-02-29 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Teva Pharmaceuticals USA, Inc. | c4936878-1643-4e7f-9b0d-e4957935aef2 | 2024-02-01 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ELESTRIN | ESTRADIOL | Viatris Specialty LLC | eff2dea1-f117-11e3-ac10-0800200c9a66 | 2023-12-15 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | A-S Medication Solutions | 31646359-292c-4bca-88a4-7a89b11c3f44 | 2023-12-12 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Vivelle-Dot | ESTRADIOL | Sandoz Inc | 5ccb77f9-d47b-4381-ad5c-5b92524e1c4a | 2023-11-17 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estrogen 4X | ESTRADIOL | Nutritional Specialties, Inc. | 772c2a8a-10e2-49af-8db6-4d5ca64b1719 | 2023-07-25 | Warnings | ESTRADIOL |
| estradiol | ESTRADIOL | Zydus Lifesciences Limited | 2f2030c2-f72e-4142-9cff-540bc8fbf8a1 | 2023-04-21 | ESTRADIOL | |
| estradiol | ESTRADIOL | Zydus Lifesciences Limited | 8b672c79-0896-4d6e-b225-299e89068ad7 | 2023-04-21 | ESTRADIOL | |
| Estradiol | ESTRADIOL | Zydus Lifesciences Limited | b79fd5ea-962f-491c-b670-40efe42ccf79 | 2022-12-07 | ESTRADIOL | |
| ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | 229b4ec5-d3c8-4406-9fc5-8f633c6447b8 | 2022-10-12 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | PharmPak, Inc. | 8f8c5a0b-4d7b-a5cb-e053-2995a90a494e | 2022-10-09 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77567 | SUPPL | 2024-02-20 |
| 77543 | SUPPL | 2024-02-16 |
| 50302 | SUPPL | 2017-11-06 |
| 50286 | SUPPL | 2017-11-03 |
| 34502 | SUPPL | 2004-08-10 |
| 24774 | SUPPL | 2004-08-10 |
| 20597 | SUPPL | 2004-04-13 |
| 20596 | SUPPL | 2004-03-28 |
| 34501 | SUPPL | 2004-02-03 |
| 34500 | SUPPL | 2004-02-03 |
| 34498 | SUPPL | 2004-02-03 |
| 24773 | SUPPL | 2004-02-02 |
| 24772 | SUPPL | 2004-02-02 |
| 24769 | SUPPL | 2004-02-02 |
| 24771 | SUPPL | 2000-08-16 |
| 12441 | SUPPL | 2000-08-16 |
| 24770 | SUPPL | 2000-02-29 |
| 34499 | SUPPL | 2000-02-28 |