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 | A-S Medication Solutions | 376beb31-5fed-4aae-a16f-71a7d243d5eb | 2025-01-09 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol Vaginal | ESTRADIOL | A-S Medication Solutions | e5dbfeff-188f-4991-b2b7-f5f03987f7fb | 2025-01-09 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | PURACAP LABORATORIES, LLC | 97ace322-341a-4d52-8c63-17265ed9aa8d | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | EPIC PHARMA, LLC | 9333d92f-2585-4b99-aaea-87c01c95125e | 2025-01-07 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | A-S Medication Solutions | f7e8dd35-c12f-46be-96f9-bf9a9b6f9a90 | 2024-12-30 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | A-S Medication Solutions | 41f424ec-9d08-4fda-b21d-41e92da6e1f0 | 2024-12-30 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Evamist | ESTRADIOL | Padagis US LLC | 9a0aa631-133d-406b-9d32-8a1a99af4e50 | 2024-10-29 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | ANI Pharmaceuticals, Inc. | 3518120e-cc44-4d70-8a20-0ef2dce9a3c6 | 2024-10-28 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Proficient Rx LP | 7e570b07-2a9e-49bf-b224-1e34f6eda3ab | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | NuCare Pharmaceuticals,Inc. | 230c2eda-b0f1-d9ec-e063-6394a90a603c | 2024-09-26 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | 5e9bd73f-67db-44f9-a5ee-409eed765cd2 | 2024-09-03 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | 74baff07-15df-48a8-93b8-3a317f896a56 | 2024-08-30 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| DOTTI | ESTRADIOL | Bryant Ranch Prepack | 75fc6d3a-49b6-47ad-b704-410692010d3a | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| DOTTI | ESTRADIOL | Bryant Ranch Prepack | b119df4a-c514-4804-b1a8-b09c6058e80d | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| DOTTI | ESTRADIOL | Bryant Ranch Prepack | f419192a-eb95-4087-9fe0-0eea639ef51b | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRACE | ESTRADIOL | A-S Medication Solutions | da52a602-f2a2-4382-be07-30351c58cc4b | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| DOTTI | ESTRADIOL | Bryant Ranch Prepack | 779751dc-243a-4dc2-ae67-3669f196b205 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol Vaginal | ESTRADIOL | Bryant Ranch Prepack | e7b15ec3-e195-44a6-bdd7-9b6de2b235b8 | 2024-07-26 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | A-S Medication Solutions | 7f3c96ce-c855-4372-95ba-7759dd82bcca | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | NuCare Pharmaceuticals, Inc. | 5423c0da-eb10-20cd-e054-00144ff8d46c | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.