Application 065448
- Type
- ANDA
- Sponsor
- ISTITUTO BIO ITA SPA
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM | INJECTABLE;INJECTION | 5,000,000 UNITS/VIAL | No | No |
| 002 | PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM | INJECTABLE;INJECTION | 20,000,000 UNITS/VIAL | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70860-126 | Penicillin G Potassium | penicillin g potassium | Athenex Pharmaceutical Division, LLC. | ANDA | Current |
| 70860-127 | Penicillin G Potassium | penicillin g potassium | Athenex Pharmaceutical Division, LLC. | ANDA | Current |