Application 075259
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DACARBAZINE | DACARBAZINE | INJECTABLE;INJECTION | 500MG/VIAL | No | Yes |
| 002 | DACARBAZINE | DACARBAZINE | INJECTABLE;INJECTION | 200MG/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0703-5075 | Dacarbazine | Dacarbazine | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-5075 | Dacarbazine | Dacarbazine | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-5075 | Dacarbazine | Dacarbazine | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-5075 | Dacarbazine | Dacarbazine | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-5075 | Dacarbazine | Dacarbazine | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-5075 | Dacarbazine | Dacarbazine | Teva Parenteral Medicines, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30822 | ORIG | 1998-08-27 |