Application 050740
- Type
- NDA
- Sponsor
- ASTELLAS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMBISOME | AMPHOTERICIN B | INJECTABLE, LIPOSOMAL;INJECTION | 50MG/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0469-3051 | AmBisome | amphotericin B | Astellas Pharma US, Inc. | NDA | Current |
| 0469-3051 | AmBisome | amphotericin B | Astellas Pharma US, Inc. | NDA | Current |
| 0469-3051 | AmBisome | amphotericin B | Astellas Pharma US, Inc. | NDA | Current |
| 0469-3051 | AmBisome | amphotericin B | Astellas Pharma US, Inc. | NDA | Current |
| 0469-3051 | AmBisome | amphotericin B | Astellas Pharma US, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80181 | SUPPL | 2024-11-07 |
| 80173 | SUPPL | 2024-11-05 |
| 69290 | SUPPL | 2021-11-10 |
| 66098 | SUPPL | 2021-02-05 |
| 66097 | SUPPL | 2021-02-05 |
| 62949 | SUPPL | 2020-05-13 |
| 62942 | SUPPL | 2020-05-13 |
| 8152 | SUPPL | 2012-03-13 |
| 18151 | SUPPL | 2012-03-09 |
| 22212 | ORIG | 2009-06-19 |
| 39221 | SUPPL | 2008-11-07 |
| 30417 | SUPPL | 2008-10-14 |
| 42711 | SUPPL | 2004-05-27 |
| 18150 | SUPPL | 2003-09-26 |
| 30416 | SUPPL | 2003-09-25 |
| 42710 | SUPPL | 2003-07-31 |
| 18149 | SUPPL | 2000-07-18 |
| 8151 | SUPPL | 2000-07-18 |
| 18148 | SUPPL | 2000-01-28 |
| 8150 | SUPPL | 2000-01-28 |