Application 200170
- Type
- ANDA
- Sponsor
- MYLAN LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/VIAL | No | No |
| 002 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67457-436 | Doxorubicin Hydrochloride | Doxorubicin Hydrochloride | Mylan Institutional LLC | ANDA | Current |