Application 207356
- Type
- NDA
- Sponsor
- INSMED INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARIKAYCE KIT | AMIKACIN SULFATE | SUSPENSION, LIPOSOMAL;INHALATION | EQ 590MG BASE/8.4ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 71558-590 | ARIKAYCE | Amikacin | Insmed Incorporated | NDA | Current |
| 71558-590 | ARIKAYCE | Amikacin | Insmed Incorporated | NDA | Current |
| 71558-590 | ARIKAYCE | Amikacin | Insmed Incorporated | NDA | Current |
| 71558-590 | ARIKAYCE | Amikacin | Insmed Incorporated | NDA | Current |
| 71558-590 | ARIKAYCE | Amikacin | Insmed Incorporated | NDA | Current |
| 71558-590 | ARIKAYCE | Amikacin | Insmed Incorporated | NDA | Current |
| 71558-590 | ARIKAYCE | Amikacin | Insmed Incorporated | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84405 | SUPPL | 2025-12-15 |
| 84367 | SUPPL | 2025-12-09 |
| 74619 | SUPPL | 2023-06-23 |
| 74425 | SUPPL | 2023-06-02 |
| 73475 | SUPPL | 2023-02-13 |
| 73467 | SUPPL | 2023-02-13 |
| 64964 | SUPPL | 2020-10-21 |
| 62157 | SUPPL | 2020-03-17 |
| 62147 | SUPPL | 2020-03-16 |
| 62146 | SUPPL | 2020-03-16 |
| 58788 | ORIG | 2019-05-20 |
| 55859 | ORIG | 2018-10-10 |
| 55673 | ORIG | 2018-09-28 |