Application 063000
- Type
- ANDA
- Sponsor
- XGEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POLYMYXIN B SULFATE | POLYMYXIN B SULFATE | INJECTABLE;INJECTION | EQ 500,000 UNITS BASE/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 39822-0166 | Polymyxin B | Polymyxin B | X-GEN Pharmaceuticals, Inc. | ANDA | Current |
| 39822-0166 | Polymyxin B | Polymyxin B | X-GEN Pharmaceuticals, Inc. | ANDA | Current |
| 39822-0166 | Polymyxin B | Polymyxin B | XGen Pharmaceuticals DJB, Inc. | ANDA | Current |