Application 065033
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | INJECTABLE;INJECTION | EQ 15 UNITS BASE/VIAL | No | No |
| 002 | BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | INJECTABLE;INJECTION | EQ 30 UNITS BASE/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0703-3154 | Bleomycin | Bleomycin | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-3154 | Bleomycin | Bleomycin | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-3155 | Bleomycin | Bleomycin | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-3155 | Bleomycin | Bleomycin | Teva Parenteral Medicines, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8375 | ORIG | 2000-06-27 |