Application 090479
- Type
- ANDA
- Sponsor
- WATSON LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NORGESTIMATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORGESTIMATE | TABLET;ORAL-28 | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | No | No |
| 002 | NORGESTIMATE; ETHINYL ESTRADIOL | NORGESTIMATE; ETHINYL ESTRADIOL | TABLET; ORAL | 0.215MG; 0.025MG | No | No |
| 003 | NORGESTIMATE; ETHINYL ESTRADIOL | NORGESTIMATE; ETHINYL ESTRADIOL | TABLET; ORAL | 0.25MG; 0.025MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORGESTIMATE | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 |
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 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A090479-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | 2011-03-09 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| norgestimate and ethinyl estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | PD-Rx Pharmaceuticals, Inc. | 2385591b-70ee-0577-e063-6394a90a9357 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | norgestimate and ethinyl estradiol |
| Norgestimate and Ethinyl Estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | A-S Medication Solutions | 35c6507c-555a-45ed-aaf6-8695831de71a | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | Norgestimate and Ethinyl Estradiol |
| Norgestimate and Ethinyl Estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | Glenmark Pharmaceuticals Inc., USA | 8b247e46-203e-4f5b-b5a7-cbd57341c735 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | Norgestimate and Ethinyl Estradiol |
| Norgestimate and ethinyl estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | Lupin Pharmaceuticals, Inc. | 6e8bec6f-17ba-4b37-ae6c-07657815f248 | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | Norgestimate and ethinyl estradiol |
| Norgestimate and Ethinyl Estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | Lupin Pharmaceuticals, Inc. | c25cd86c-2940-475a-9628-ee75b0294e8d | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | Norgestimate and Ethinyl Estradiol |
| Norgestimate and Ethinyl Estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | PD-Rx Pharmaceuticals, Inc. | 00dd9b78-dd90-414b-b241-7619aa9d1ed2 | 2025-04-08 | Boxed warning, Warnings, Adverse reactions | Norgestimate and Ethinyl Estradiol |
| Norgestimate and ethinyl estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | Naari Pte Limited | b936a6fb-27ed-44de-9199-8c656bcd366e | 2024-04-23 | Boxed warning, Warnings, Adverse reactions | Norgestimate and ethinyl estradiol |
| Norgestimate and ethinyl estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | Naari Pte Limited | 03de435b-b8fb-4faa-a0ec-01e48b5aaae4 | 2024-04-23 | Boxed warning, Warnings, Adverse reactions | Norgestimate and ethinyl estradiol |
| Norgestimate and Ethinyl Estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | AvKARE | a3c0c983-7ec7-244a-e053-2995a90adbe4 | 2024-01-10 | Boxed warning, Warnings, Adverse reactions | Norgestimate and Ethinyl Estradiol |
| Norgestimate and Ethinyl Estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | AvKARE | a3ce752d-58df-363d-e053-2a95a90a5411 | 2024-01-10 | Boxed warning, Warnings, Adverse reactions | Norgestimate and Ethinyl Estradiol |
| norgestimate and ethinyl estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | AvKARE | a3cfd79e-a344-1dfc-e053-2995a90a1ab7 | 2024-01-10 | Boxed warning, Warnings, Adverse reactions | norgestimate and ethinyl estradiol |
| Norgestimate and Ethinyl Estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | A-S Medication Solutions | 6ae97238-28cf-4bc9-a4ba-1e2bf4e3c600 | 2023-03-28 | Boxed warning, Warnings, Adverse reactions | Norgestimate and Ethinyl Estradiol |
| Norgestimate and Ethinyl Estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | Proficient Rx LP | 4a159dcd-8af4-4e59-8f46-7b0fe5c22807 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | Norgestimate and Ethinyl Estradiol |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.