Application 203999
- Type
- ANDA
- Sponsor
- XGEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DACTINOMYCIN | DACTINOMYCIN | INJECTABLE;INJECTION | 0.5MG/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 39822-2100 | dactinomycin | dactinomycin | X-GEN Pharmaceuticals, Inc. | ANDA | Current |
| 39822-2100 | dactinomycin | dactinomycin | X-GEN Pharmaceuticals, Inc. | ANDA | Current |
| 39822-2100 | dactinomycin | dactinomycin | XGen Pharmaceuticals DJB, Inc. | ANDA | Current |