Application 021045
- Type
- NDA
- Sponsor
- FDN CONSUMER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PLAN B | LEVONORGESTREL | TABLET;ORAL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | PLAN B | LEVONORGESTREL | TABLET;ORAL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021045-001 | PLAN B | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | |
| N021045-002 | PLAN B | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021045-001 | PLAN B | 0.75MG | TABLET / ORAL | RLD | 1999-07-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021045-002 | PLAN B | 0.75MG | TABLET / ORAL | RLD | 2006-08-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021045-001 | PLAN B | 0.75MG | TABLET / ORAL | RLD | 1999-07-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021045-002 | PLAN B | 0.75MG | TABLET / ORAL | RLD | 2006-08-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1999-07-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2006-08-24 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1999-07-28 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2006-08-24 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| SheWise | LEVONORGESTREL | GLENMARK THERAPEUTICS INC., USA | 7be13a7e-b4ff-4fe1-82a6-f9914596d72a | 2026-07-15 | Warnings | LEVONORGESTREL |
| Levonorgestrel | LEVONORGESTREL | GLENMARK THERAPEUTICS INC., USA | 07567b80-d8a1-41c0-95e4-33afa584bbc4 | 2026-07-15 | Warnings | LEVONORGESTREL |
| OPTION 2 | LEVONORGESTREL | L. Perrigo Company | 7d7b9e61-9f3d-477d-b74d-b0cc725f9bba | 2026-06-25 | Warnings | LEVONORGESTREL |
| Levonorgestrel | LEVONORGESTREL | Rugby Laboratories | 076126e4-9d76-45cd-a86b-5b35c56b620a | 2026-05-13 | Warnings | LEVONORGESTREL |
| LEADER Emergency Contraceptive Levonorgestrel | LEVONORGESTREL | Cardinal Health 110, LLC. DBA Leader | d1e33615-0a98-4223-833d-843c758d9db7 | 2026-05-06 | Warnings | LEVONORGESTREL |
| My Choice | LEVONORGESTREL | OHM LABORATORIES INC | 500d9418-69a8-f4f3-e063-6394a90a9b66 | 2026-04-22 | Warnings | LEVONORGESTREL |
| LEVONORGESTREL | LEVONORGESTREL | Camber Consumer Care Inc | 2e22d0c4-b308-4a02-b2b0-2c06fb91d1e5 | 2026-03-23 | Warnings | LEVONORGESTREL |
| Skyla | LEVONORGESTREL | Bayer HealthCare Pharmaceuticals Inc. | 9f44ff35-e052-49cd-a1c2-0bfd87d49309 | 2026-03-04 | Warnings, Adverse reactions | LEVONORGESTREL |
| Restart | LEVONORGESTREL | Winx Health Inc. | 0cdf198e-c114-b9fa-e063-6294a90a566a | 2026-02-24 | Warnings | LEVONORGESTREL |
| Levonorgestrel | LEVONORGESTREL | YYBA Corp | 49008f10-8a70-3c08-e063-6294a90a44a3 | 2026-02-03 | Warnings | LEVONORGESTREL |
| Her Style | LEVONORGESTREL | Ingenus Pharmaceuticals, LLC | 6e631755-b7c5-4a3a-b46d-f66b4ceedb1c | 2025-12-05 | Warnings | LEVONORGESTREL |
| New Day | LEVONORGESTREL | Northstar Rx LLC | 9e8c96f6-ab51-4721-b276-1ca02a712510 | 2025-12-05 | Warnings | LEVONORGESTREL |
| My Way | LEVONORGESTREL | Lupin Pharmaceuticals, Inc. | 3efec61d-e0a6-49c5-9b88-834db6d171fd | 2025-12-02 | Warnings | LEVONORGESTREL |
| Julie Morning After Pill | LEVONORGESTREL | Julie Products Inc. | 40bb96f0-d5f1-1ec3-e063-6294a90a74b1 | 2025-11-26 | Warnings | LEVONORGESTREL |
| Julie Morning After Pill | LEVONORGESTREL | Julie Products Inc. | 40bbad6f-0c54-e4ed-e063-6394a90af3ad | 2025-11-14 | Warnings | LEVONORGESTREL |
| Mirena | LEVONORGESTREL | Bayer HealthCare Pharmaceuticals Inc. | dcbd6aa2-b3fa-479a-a676-56ea742962fc | 2025-10-29 | Warnings, Adverse reactions | LEVONORGESTREL |
| Kyleena | LEVONORGESTREL | Bayer HealthCare Pharmaceuticals Inc. | 2e07c155-21e1-4781-9633-ce8bddd47080 | 2025-10-23 | Warnings, Adverse reactions | LEVONORGESTREL |
| Julie | LEVONORGESTREL | Julie Products Inc | 2e9784da-2186-a630-e063-6294a90a8493 | 2025-07-14 | Warnings | LEVONORGESTREL |
| Levonorgestrel | LEVONORGESTREL | Ohm Laboratories Inc. | f3f2a41a-a9af-4d63-81d8-33181d12af40 | 2025-07-04 | Warnings | LEVONORGESTREL |
| AfterPill | LEVONORGESTREL | Syzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880 | 4d284ba4-9cd7-48e4-95b9-cd6d0367bfd1 | 2025-05-01 | Warnings | LEVONORGESTREL |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77914 | SUPPL | 2024-03-22 |
| 77913 | SUPPL | 2024-03-22 |
| 54006 | SUPPL | 2018-05-03 |
| 53863 | SUPPL | 2018-04-27 |
| 49897 | SUPPL | 2017-09-29 |
| 49883 | SUPPL | 2017-09-29 |
| 4156 | SUPPL | 2009-11-20 |
| 35975 | SUPPL | 2009-08-14 |
| 21387 | SUPPL | 2006-08-29 |
| 35974 | SUPPL | 2006-08-24 |
| 4155 | SUPPL | 2006-08-24 |
| 44090 | ORIG | 2006-08-23 |
| 41902 | ORIG | 1999-07-28 |
| 26587 | ORIG | 1999-07-28 |
| 14244 | ORIG | 1999-07-28 |