Application 211188
- Type
- ANDA
- Sponsor
- MEDEFIL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | LIQUID;N/A | 100% (1ML) | No | No |
| 002 | STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | LIQUID;N/A | 100% (2.5ML) | No | Yes |
| 003 | STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | LIQUID;N/A | 100% (3ML) | No | Yes |
| 004 | STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | LIQUID;N/A | 100% (5ML) | No | Yes |
| 005 | STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | LIQUID;N/A | 100% (10ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 64253-020 | Sterile Water | Sterile Water for Injection | Medefil, Inc. | ANDA | Current |
| 64253-020 | Sterile Water | Sterile Water for Injection | Medefil, Inc. | ANDA | Current |
| 64253-020 | Sterile Water | Sterile Water for Injection | Medefil, Inc. | ANDA | Current |