| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 217673 | NDA | INSMED INC | 001 | BRINSUPRI | TABLET;ORAL | 10MG | BRENSOCATIB | 2025-08-12 | Prescription | No | |
| 002 | BRINSUPRI | TABLET;ORAL | 25MG | BRENSOCATIB | 2025-08-12 | Prescription | Yes | ||||
| 207356 | NDA | INSMED INC | 001 | ARIKAYCE KIT | SUSPENSION, LIPOSOMAL;INHALATION | EQ 590MG BASE/8.4ML | AMIKACIN SULFATE | 2018-09-28 | Prescription | Yes | |
| 021884 | BLA | INSMED | 001 | IPLEX | INJECTABLE;SUBCUTANEOUS | 36MG/0.6ML | MECASERMIN RINFABATE RECOMBINANT | 2005-12-12 | Discontinued | No |