Application 020221
- Type
- NDA
- Sponsor
- CLINIGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ETHYOL | AMIFOSTINE | INJECTABLE;INJECTION | 500MG/VIAL | Yes | Yes |
| 002 | ETHYOL | AMIFOSTINE | INJECTABLE;INJECTION | 375MG/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66220-017 | Ethyol | amifostine | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-017 | Ethyol | amifostine | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-017 | Ethyol | amifostine | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 76310-017 | Ethyol | amifostine | Clinigen Group PLC | NDA | Current |
| 76310-017 | Ethyol | amifostine | Clinigen Group PLC | NDA | Current |
| 76310-017 | Ethyol | amifostine | Clinigen Limited | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 59500 | SUPPL | 2019-07-30 |
| 59462 | SUPPL | 2019-07-26 |
| 57643 | ORIG | 2019-02-15 |
| 48561 | SUPPL | 2017-05-30 |
| 48557 | SUPPL | 2017-05-30 |
| 46219 | SUPPL | 2016-12-19 |
| 46217 | SUPPL | 2016-12-19 |
| 24597 | SUPPL | 2008-11-13 |
| 12329 | SUPPL | 2008-11-12 |
| 24596 | SUPPL | 2006-04-05 |
| 24595 | SUPPL | 2003-04-15 |
| 34388 | SUPPL | 2003-03-28 |
| 2185 | SUPPL | 2002-02-20 |
| 34387 | SUPPL | 1999-06-24 |
| 20540 | SUPPL | 1999-06-24 |
| 2184 | SUPPL | 1999-06-24 |