Application 060657
- Type
- ANDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PFIZERPEN | PENICILLIN G POTASSIUM | INJECTABLE;INJECTION | 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | PFIZERPEN | PENICILLIN G POTASSIUM | INJECTABLE;INJECTION | 5,000,000 UNITS/VIAL | No | Yes |
| 003 | PFIZERPEN | PENICILLIN G POTASSIUM | INJECTABLE;INJECTION | 20,000,000 UNITS/VIAL | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0049-0420 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0420 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0420 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0420 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0430 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0430 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0430 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0430 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0520 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0520 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0520 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0520 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0520 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0520 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0520 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0520 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0520 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0530 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0530 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0530 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0530 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0530 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0530 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0530 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0530 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |
| 0049-0530 | Pfizerpen | penicillin G potassium | Roerig | ANDA | Current |