Application 064097
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/100ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0143-9087 | Doxorubicin Hydrochloride | Doxorubicin Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9091 | Doxorubicin Hydrochloride | Doxorubicin Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9372 | Adriamycin | Doxorubicin Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9372 | Adriamycin | Doxorubicin Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9546 | Adriamycin | Doxorubicin Hydrochloride | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9546 | Adriamycin | Doxorubicin Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9546 | Adriamycin | Doxorubicin Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 39410 | SUPPL | 2012-12-12 |