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| PLAN B | LEVONORGESTREL | TABLET;ORAL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PLAN B | LEVONORGESTREL | TABLET;ORAL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| N021045-001 | PLAN B | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | |
| N021045-002 | PLAN B | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021045-002 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-08-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021045-001 | PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-07-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 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… |
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 |
|---|---|---|---|---|---|---|
| Levonorgestrel | LEVONORGESTREL | Xiromed LLC | 626a2333-ff56-ef28-a287-b33bacc0302a | 2023-09-05 | Warnings | LEVONORGESTREL |
| LILETTA | LEVONORGESTREL | Allergan, Inc. | aaf0eb2a-f88a-4f26-a445-0fd30176c326 | 2023-06-29 | Warnings, Adverse reactions | LEVONORGESTREL |
| Levonorgestrel | LEVONORGESTREL | Naari Pte Limited | be8b7ace-9af8-4417-85fa-863e19072887 | 2023-03-16 | Warnings | LEVONORGESTREL |
| Next Choice One Dose | LEVONORGESTREL | Foundation Consumer Healthcare LLC | 504735bd-6af9-4588-bf85-d09dbf2a7e41 | 2023-02-02 | Warnings | LEVONORGESTREL |
| Take Action | LEVONORGESTREL | Foundation Consumer Healthcare LLC | 78eee7c9-5ca5-45af-898f-92a2f3b2598e | 2023-01-31 | Warnings | LEVONORGESTREL |
| Aftera | LEVONORGESTREL | Foundation Consumer Healthcare LLC | 53ad8dff-9134-475c-90b3-8087753e17c4 | 2023-01-31 | Warnings | LEVONORGESTREL |
| Plan B One-Step | LEVONORGESTREL | Foundation Consumer Healthcare LLC | 6ce6b40e-14ac-47bd-a648-ddf9e452e559 | 2023-01-31 | Warnings | LEVONORGESTREL |
| Opcicon One-Step | LEVONORGESTREL | Sun Pharmaceutical Industries, Inc. | b67ca313-561e-471f-baf3-257b7e253c75 | 2023-01-13 | Warnings | LEVONORGESTREL |
| Morning After | LEVONORGESTREL | Rapha Pharmaceuticals, Inc. | f0fab784-3d28-35fb-e053-2995a90ab611 | 2022-12-29 | Warnings | LEVONORGESTREL |
| My Choice TM | LEVONORGESTREL | Proficient Rx LP | 165f7270-d050-4e97-b30f-107b96940d84 | 2022-09-01 | Warnings | LEVONORGESTREL |
| My Choice TM | LEVONORGESTREL | SUN PHARMACEUTICAL INDUSTRIES, INC. | 66753300-fb61-4f09-af74-ee498b0bd595 | 2022-04-21 | Warnings | LEVONORGESTREL |
| Option 2 | LEVONORGESTREL | L. Perrigo Company | 9b9e9352-3e4d-4ec3-96aa-8fd58d82fe96 | 2020-07-30 | Warnings | LEVONORGESTREL |
| AfterPlan | LEVONORGESTREL | SUN PHARMACEUTICAL INDUSTRIES, INC. | c30c7bc2-04fa-4590-96f5-5bcf4bba3f1a | 2018-10-26 | Warnings | LEVONORGESTREL |
| Morning After | LEVONORGESTREL | Rapha Pharmaceuticals, Inc. | 677aa953-3c30-4ce5-e053-2991aa0ab2b2 | 2018-03-15 | Warnings | LEVONORGESTREL |
| Levonorgestrel | LEVONORGESTREL | Novel Laboratories, Inc. | ac13a073-a33a-45f7-8483-eecc9190195f | 2017-09-15 | LEVONORGESTREL | |
| My Way | LEVONORGESTREL | Lupin Pharmaceuticals,Inc. | ec01077e-ac3c-424a-9edc-0854fe0a2e0d | 2016-06-17 | Warnings | LEVONORGESTREL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |