Application 050661
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IDAMYCIN | IDARUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/VIAL | No | No |
| 002 | IDAMYCIN | IDARUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/VIAL | No | No |
| 003 | IDAMYCIN | IDARUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 20MG/VIAL | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71016 | SUPPL | 2022-05-06 |
| 71003 | SUPPL | 2022-05-05 |
| 66252 | SUPPL | 2021-02-17 |
| 66193 | SUPPL | 2021-02-11 |
| 59590 | SUPPL | 2019-08-06 |
| 59572 | SUPPL | 2019-08-05 |
| 17982 | SUPPL | 2014-12-10 |
| 30233 | SUPPL | 2014-12-05 |
| 7945 | SUPPL | 2002-10-11 |
| 7944 | SUPPL | 2002-09-30 |