Application 203159
- Type
- NDA
- Sponsor
- BAYER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SKYLA | LEVONORGESTREL | INTRAUTERINE DEVICE;INTRAUTERINE | 13.5MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50419-422 | Skyla | Levonorgestrel | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-422 | Skyla | Levonorgestrel | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-422 | Skyla | Levonorgestrel | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-422 | Skyla | Levonorgestrel | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-422 | Skyla | Levonorgestrel | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-422 | Skyla | Levonorgestrel | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 74180 | SUPPL | 2023-05-05 |
| 74192 | SUPPL | 2023-05-04 |
| 69869 | SUPPL | 2022-01-13 |
| 69867 | SUPPL | 2022-01-13 |
| 67548 | SUPPL | 2021-05-19 |
| 67543 | SUPPL | 2021-05-18 |
| 52813 | SUPPL | 2018-03-05 |
| 52793 | SUPPL | 2018-03-02 |
| 47501 | SUPPL | 2017-03-08 |
| 47474 | SUPPL | 2017-03-06 |
| 46521 | SUPPL | 2016-12-23 |
| 46505 | SUPPL | 2016-12-21 |
| 45805 | SUPPL | 2016-11-04 |
| 45798 | SUPPL | 2016-11-03 |
| 40268 | SUPPL | 2016-04-12 |
| 10175 | SUPPL | 2016-04-11 |
| 44878 | ORIG | 2013-10-04 |
| 22913 | ORIG | 2013-10-04 |
| 19438 | SUPPL | 2013-09-17 |
| 10174 | SUPPL | 2013-09-17 |
| 19437 | SUPPL | 2013-08-09 |
| 10173 | SUPPL | 2013-08-08 |
| 32384 | ORIG | 2013-01-11 |
| 19436 | ORIG | 2013-01-11 |
| 51308 | ORIG | 1900-01-01 |
| 51307 | ORIG | 1900-01-01 |
| 51306 | ORIG | 1900-01-01 |