Application 017279
- Type
- NDA
- Sponsor
- ISOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLOFIL-125 | IOTHALAMATE SODIUM I-125 | INJECTABLE;INJECTION | 250-300uCi/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50914-7729 | Glofil-125 | Sodium Iothalamate I-125 injection | Iso-Tex Diagnostics, Inc. | NDA | Current |
| 50914-7729 | Glofil-125 | Sodium Iothalamate I-125 injection | Iso-Tex Diagnostics, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 13104 | SUPPL | 2002-01-22 |