Application 040312
- Type
- ANDA
- Sponsor
- NOVO NORDISK INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INNOFEM | ESTRADIOL | TABLET;ORAL | 0.5MG | No | No |
| 002 | INNOFEM | ESTRADIOL | TABLET;ORAL | 1MG | No | No |
| 003 | INNOFEM | ESTRADIOL | TABLET;ORAL | 2MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040312-001 | INNOFEM | ESTRADIOL | 0.5MG | TABLET / ORAL | 1999-11-19 | ||
| A040312-002 | INNOFEM | ESTRADIOL | 1MG | TABLET / ORAL | 1999-11-19 | ||
| A040312-003 | INNOFEM | ESTRADIOL | 2MG | TABLET / ORAL | 1999-11-19 |
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 | A040312-001 | INNOFEM | 0.5MG | TABLET / ORAL | 1999-11-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040312-002 | INNOFEM | 1MG | TABLET / ORAL | 1999-11-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040312-003 | INNOFEM | 2MG | TABLET / ORAL | 1999-11-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040312-001 | INNOFEM | 0.5MG | TABLET / ORAL | 1999-11-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040312-002 | INNOFEM | 1MG | TABLET / ORAL | 1999-11-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040312-003 | INNOFEM | 2MG | TABLET / ORAL | 1999-11-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040312-001 | INNOFEM | 0.5MG | TABLET / ORAL | 1999-11-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040312-002 | INNOFEM | 1MG | TABLET / ORAL | 1999-11-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040312-003 | INNOFEM | 2MG | TABLET / ORAL | 1999-11-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040312-001 | INNOFEM | 0.5MG | TABLET / ORAL | 1999-11-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040312-002 | INNOFEM | 1MG | TABLET / ORAL | 1999-11-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040312-003 | INNOFEM | 2MG | TABLET / ORAL | 1999-11-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040312-001 | INNOFEM | 0.5MG | TABLET / ORAL | 1999-11-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040312-002 | INNOFEM | 1MG | TABLET / ORAL | 1999-11-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040312-003 | INNOFEM | 2MG | TABLET / ORAL | 1999-11-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040312-001 | INNOFEM | 0.5MG | TABLET / ORAL | 1999-11-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040312-002 | INNOFEM | 1MG | TABLET / ORAL | 1999-11-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040312-003 | INNOFEM | 2MG | TABLET / ORAL | 1999-11-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040312-001 | INNOFEM | 0.5MG | TABLET / ORAL | 1999-11-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040312-002 | INNOFEM | 1MG | TABLET / ORAL | 1999-11-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040312-003 | INNOFEM | 2MG | TABLET / ORAL | 1999-11-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040312-001 | INNOFEM | 0.5MG | TABLET / ORAL | 1999-11-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040312-002 | INNOFEM | 1MG | TABLET / ORAL | 1999-11-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040312-003 | INNOFEM | 2MG | TABLET / ORAL | 1999-11-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040312-001 | INNOFEM | 0.5MG | TABLET / ORAL | 1999-11-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040312-002 | INNOFEM | 1MG | TABLET / ORAL | 1999-11-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040312-003 | INNOFEM | 2MG | TABLET / ORAL | 1999-11-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040312-001 | INNOFEM | 0.5MG | TABLET / ORAL | 1999-11-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040312-002 | INNOFEM | 1MG | TABLET / ORAL | 1999-11-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040312-003 | INNOFEM | 2MG | TABLET / ORAL | 1999-11-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040312-001 | INNOFEM | 0.5MG | TABLET / ORAL | 1999-11-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040312-002 | INNOFEM | 1MG | TABLET / ORAL | 1999-11-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040312-003 | INNOFEM | 2MG | TABLET / ORAL | 1999-11-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040312-001 | INNOFEM | 0.5MG | TABLET / ORAL | 1999-11-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040312-002 | INNOFEM | 1MG | TABLET / ORAL | 1999-11-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040312-003 | INNOFEM | 2MG | TABLET / ORAL | 1999-11-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040312-001 | INNOFEM | 0.5MG | TABLET / ORAL | 1999-11-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040312-002 | INNOFEM | 1MG | TABLET / ORAL | 1999-11-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040312-003 | INNOFEM | 2MG | TABLET / ORAL | 1999-11-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040312-001 | INNOFEM | 0.5MG | TABLET / ORAL | 1999-11-19 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| DOTTI | ESTRADIOL | Bryant Ranch Prepack | 99b889a0-6200-4727-97d3-f5a0b7814e1b | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | 9eb88585-4994-474f-bd63-c4e003bf6f20 | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | 7eb1b2c3-8ece-47c3-96c0-606f7f5b5a32 | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | d9514497-6b9e-4c13-950b-6b036ff101c1 | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | NuCare Pharmaceuticals,Inc. | 1bbdb10b-9a32-3899-e063-6294a90ab26d | 2024-06-25 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | NuCare Pharmaceuticals,Inc. | 7093dbe4-b096-2ddb-e053-2991aa0a1bb8 | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRACE | ESTRADIOL | Allergan, Inc. | dfc41fcd-c5ba-4b25-b647-cf04d3988b3e | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Amneal Pharmaceuticals NY LLC | d4259bb8-91f8-4587-8ceb-35d44145aec0 | 2024-05-15 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| LYLLANA | ESTRADIOL | Amneal Pharmaceuticals LLC | 09c472c6-a38a-4a3d-b048-6fefd52e2ad3 | 2024-05-15 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Amneal Pharmaceuticals NY LLC | 0500ee9b-bf4a-4432-9afe-20a7d60a6fe5 | 2024-05-14 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| DOTTI | ESTRADIOL | Amneal Pharmaceuticals LLC | 53016d30-6b5f-49da-ac16-85ef415a5805 | 2024-05-14 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | 0e927450-3f02-4d2f-9235-a255357e8d93 | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | 6a4e82a4-d980-4c04-9e33-9444a292728a | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | eab9a629-b3d4-4faf-bce4-656fe3b46d38 | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | ANI Pharmaceuticals, Inc. | 3fe899db-a8cd-4a31-88fb-1129be96b4d9 | 2024-04-15 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Noven Therapeutics, LLC | bf185599-2138-4083-9c52-2b95dce09ae0 | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | 80d6644a-d6f2-48e7-a685-92c4255b19fe | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | 414b846a-d6d9-4e8a-9632-12e296fc13c3 | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| YUVAFEM | ESTRADIOL | Amneal Pharmaceuticals LLC | 30c7f6ba-7a9e-4853-b3e4-e00a46560224 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Amneal Pharmaceuticals of New York LLC | 094830ee-1b1c-4cf7-8a39-427dfd56f9c9 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.