Application 020683
- Type
- NDA
- Sponsor
- CADENCE HEALTH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALESSE | ETHINYL ESTRADIOL; LEVONORGESTREL | TABLET;ORAL-21 | 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | ALESSE | ETHINYL ESTRADIOL; LEVONORGESTREL | TABLET;ORAL-28 | 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79134 | SUPPL | 2024-07-22 |
| 79106 | SUPPL | 2024-07-17 |
| 70977 | SUPPL | 2022-05-04 |
| 70929 | SUPPL | 2022-05-03 |
| 53491 | SUPPL | 2018-03-28 |
| 53253 | SUPPL | 2018-03-23 |
| 49427 | SUPPL | 2017-08-16 |
| 49307 | SUPPL | 2017-08-10 |
| 35128 | SUPPL | 2008-02-14 |
| 13190 | SUPPL | 2008-02-14 |
| 13189 | SUPPL | 2008-02-14 |
| 3067 | SUPPL | 2008-02-05 |
| 3066 | SUPPL | 2008-02-05 |
| 3065 | SUPPL | 2008-02-05 |
| 20817 | ORIG | 2003-08-08 |