Application 022472
- Type
- BLA
- Sponsor
- MANNKIND
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AFREZZA | INSULIN RECOMBINANT HUMAN | POWDER;INHALATION | 4 UNITS/INH | No | No |
| 002 | AFREZZA | INSULIN RECOMBINANT HUMAN | POWDER;INHALATION | 8 UNITS/INH | No | No |
| 003 | AFREZZA | INSULIN RECOMBINANT HUMAN | POWDER;INHALATION | 12 UNITS/INH | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47918-874 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
| 47918-874 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
| 47918-874 | Afrezza | Insulin Human | Mannkind Corporation | NDA | Current |
| 47918-874 | Afrezza | Insulin Human | Mannkind Corporation | NDA | Current |
| 47918-874 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
| 47918-878 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
| 47918-878 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
| 47918-878 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
| 47918-878 | Afrezza | Insulin Human | Mannkind Corporation | NDA | Current |
| 47918-878 | Afrezza | Insulin Human | Mannkind Corporation | NDA | Current |
| 47918-880 | Afrezza | Insulin Human | Mannkind Corporation | NDA | Current |
| 47918-880 | Afrezza | Insulin Human | Mannkind Corporation | NDA | Current |
| 47918-880 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
| 47918-880 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
| 47918-880 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
| 47918-882 | Afrezza | Insulin Human | Mannkind Corporation | NDA | Current |
| 47918-891 | Afrezza | Insulin Human | Mannkind Corporation | NDA | Current |
| 47918-891 | Afrezza | Insulin Human | Mannkind Corporation | NDA | Current |
| 47918-891 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
| 47918-891 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
| 47918-891 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
| 47918-894 | Afrezza | Insulin Human | Mannkind Corporation | NDA | Current |
| 47918-898 | Afrezza | Insulin Human | Mannkind Corporation | NDA | Current |
| 47918-898 | Afrezza | Insulin Human | Mannkind Corporation | NDA | Current |
| 47918-898 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
| 47918-898 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
| 47918-898 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
| 47918-902 | Afrezza | Insulin Human | Mannkind Corporation | NDA | Current |
| 47918-902 | Afrezza | Insulin Human | Mannkind Corporation | NDA | Current |
| 47918-902 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
| 47918-902 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
| 47918-902 | Afrezza | Insulin Human | Mannkind Corporation | BLA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 84845 | SUPPL | 2026-01-28 |
| 84844 | SUPPL | 2026-01-28 |
| 84837 | SUPPL | 2026-01-26 |
| 84836 | SUPPL | 2026-01-26 |
| 73386 | SUPPL | 2023-02-06 |
| 73381 | SUPPL | 2023-02-06 |
| 56144 | SUPPL | 2020-03-23 |
| 56111 | SUPPL | 2020-03-23 |
| 53810 | SUPPL | 2020-03-23 |
| 49923 | SUPPL | 2020-03-23 |
| 49905 | SUPPL | 2020-03-23 |
| 49904 | SUPPL | 2020-03-23 |
| 44759 | ORIG | 2020-03-23 |
| 44505 | ORIG | 2020-03-23 |
| 38748 | SUPPL | 2020-03-23 |
| 38747 | ORIG | 2020-03-23 |
| 29765 | SUPPL | 2020-03-23 |
| 29764 | ORIG | 2020-03-23 |
| 22030 | ORIG | 2020-03-23 |
| 17627 | SUPPL | 2020-03-23 |
| 17626 | SUPPL | 2020-03-23 |
| 17625 | SUPPL | 2020-03-23 |
| 17624 | SUPPL | 2020-03-23 |
| 17623 | SUPPL | 2020-03-23 |
| 17622 | SUPPL | 2020-03-23 |
| 7440 | SUPPL | 2020-03-23 |
| 7439 | SUPPL | 2020-03-23 |
| 7438 | SUPPL | 2020-03-23 |
| 66368 | APPL | 2020-03-22 |