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Application 211367
- Type
- NDA
- Sponsor
- EXELTIS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SLYND | DROSPIRENONE | TABLET;ORAL | 4MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0642-7470 | SLYND | Drospirenone | Exeltis USA, Inc. | NDA | Current |
| 0642-7470 | SLYND | Drospirenone | Exeltis USA, Inc. | NDA | Current |
| 0642-7470 | SLYND | Drospirenone | Exeltis USA, Inc. | NDA | Current |
| 0642-7470 | SLYND | Drospirenone | Exeltis USA, Inc. | NDA | Current |
| 0642-7470 | SLYND | Drospirenone | Exeltis USA, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 61865 | ORIG | 2020-02-11 |
| 58859 | ORIG | 2019-05-24 |
| 58850 | ORIG | 2019-05-24 |
| 62970 | ORIG | 1900-01-01 |