Application 206229
- Type
- NDA
- Sponsor
- MEDICINES360
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LILETTA | LEVONORGESTREL | INTRAUTERINE DEVICE;INTRAUTERINE | 52MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0023-5858 | LILETTA | Levonorgestrel | Allergan, Inc. | NDA | Current |
| 0023-5858 | LILETTA | Levonorgestrel | Allergan, Inc. | NDA | Current |
| 0023-5858 | LILETTA | Levonorgestrel | Allergan, Inc. | NDA | Current |
| 0023-5858 | LILETTA | Levonorgestrel | Allergan, Inc. | NDA | Current |
| 0023-5858 | LILETTA | Levonorgestrel | Allergan, Inc. | NDA | Current |
| 0023-5858 | LILETTA | Levonorgestrel | Allergan, Inc. | NDA | Current |
| 52544-035 | LILETTA | Levonorgestrel | Actavis Pharma, Inc. | NDA | Current |
| 52544-035 | LILETTA | Levonorgestrel | Actavis Pharma, Inc. | NDA | Current |
| 52544-035 | LILETTA | Levonorgestrel | Actavis Pharma, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77622 | ORIG | 2024-02-26 |
| 74675 | SUPPL | 2023-07-03 |
| 74666 | SUPPL | 2023-06-30 |
| 72615 | SUPPL | 2022-11-14 |
| 72614 | SUPPL | 2022-11-14 |
| 72601 | SUPPL | 2022-11-13 |
| 72600 | SUPPL | 2022-11-13 |
| 62732 | SUPPL | 2020-04-29 |
| 62706 | SUPPL | 2020-04-28 |
| 60696 | SUPPL | 2019-10-29 |
| 60688 | SUPPL | 2019-10-28 |
| 56013 | SUPPL | 2018-10-18 |
| 55970 | SUPPL | 2018-10-17 |
| 49261 | SUPPL | 2017-08-07 |
| 49249 | SUPPL | 2017-08-04 |
| 46073 | ORIG | 2016-09-28 |
| 40530 | SUPPL | 2016-02-02 |
| 10551 | SUPPL | 2016-02-01 |
| 40529 | ORIG | 2015-03-18 |
| 10550 | ORIG | 2015-03-11 |
| 51301 | ORIG | 1900-01-01 |
| 51300 | ORIG | 1900-01-01 |
| 51299 | ORIG | 1900-01-01 |
| 51298 | ORIG | 1900-01-01 |