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| PLAN B | LEVONORGESTREL | TABLET;ORAL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PLAN B | LEVONORGESTREL | TABLET;ORAL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
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 |