Application 065042
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | INJECTABLE;INJECTION | EQ 30 UNITS BASE/VIAL | No | No |
| 002 | BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | INJECTABLE;INJECTION | EQ 15 UNITS BASE/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0143-9240 | Bleomycin | Bleomycin | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9240 | Bleomycin | Bleomycin | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9240 | Bleomycin | Bleomycin | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9241 | Bleomycin | Bleomycin | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9241 | Bleomycin | Bleomycin | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9241 | Bleomycin | Bleomycin | West-Ward Pharmaceuticals Corp | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 8379 | ORIG | 2003-04-10 |