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 |
|---|---|---|---|---|---|---|
| Estradiol | ESTRADIOL | Mylan Pharmaceuticals Inc. | d28bec8f-762e-4f05-a20d-96a42970d6a7 | 2025-06-17 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | NorthStar Rx LLC | 0c8a07a4-5762-eaf4-e063-6394a90a54ff | 2025-06-16 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol Vaginal Cream | ESTRADIOL | Prasco Laboratories | c895ac14-5dbd-4201-bf3e-ba7c38a4e994 | 2025-05-30 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | American Health Packaging | 265a1ee1-f314-4324-a2e1-0120a9a00a20 | 2025-05-02 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | Preferred Pharmaceuticals Inc. | 9956a196-fefd-4766-a225-e154fbd3aeff | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | A-S Medication Solutions | 3e84e3e7-4b50-407f-a215-45363b541384 | 2025-04-15 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Preferred Pharmaceuticals Inc. | 72fbd5a8-9c34-4790-84ed-79f5bd3ae0f0 | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | fad3813c-9495-416b-9789-623d5758b4e3 | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | cf1ebc1d-8f3c-4468-b565-f0da69986e7c | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | bfc1beb9-1ade-446e-97dd-55b41c2fa851 | 2025-03-25 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | PD-Rx Pharmaceuticals, Inc. | d0d1c2c8-b175-4250-9343-d7db65b72e8f | 2025-03-13 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | NuCare Pharmaceuticals,Inc. | dd7d2d2a-e76b-7dfe-e053-2995a90a790a | 2025-02-26 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | PD-Rx Pharmaceuticals, Inc. | aa396e57-0a93-49cc-82e5-cd35c987bb0b | 2025-02-20 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | A-S Medication Solutions | 8788ddd1-36a6-416a-b527-75eb41de2808 | 2025-02-18 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol Vaginal | ESTRADIOL | NuCare Pharmaceuticals, Inc. | 2e5a4d78-6683-4fb8-e063-6294a90a49e7 | 2025-02-17 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | 487ce40e-1f13-4497-994a-c5d91b87b6cc | 2025-02-13 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Vagifem | ESTRADIOL | Novo Nordisk | e5ad3cf6-dd96-4e64-af21-c1eee38d0b88 | 2025-02-10 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Direct_Rx | 032135ee-7bc9-5cdf-e063-6394a90ad9a2 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Direct_Rx | 01789bad-4be4-ae22-e063-6294a90af392 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | PharmPak, Inc. | 20b50139-4e13-4f0c-aaf5-ecb83911d9e6 | 2025-01-16 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.