Details for New Drug Application (NDA): 060657
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NDA 060657 describes PFIZERPEN, which is a drug marketed by Pfizer and is included in eight NDAs. It is available from one supplier. Additional details are available on the PFIZERPEN profile page.
The generic ingredient in PFIZERPEN is penicillin g procaine. There are ninety-two drug master file entries for this compound. Additional details are available on the penicillin g procaine profile page.
The generic ingredient in PFIZERPEN is penicillin g procaine. There are ninety-two drug master file entries for this compound. Additional details are available on the penicillin g procaine profile page.
Summary for 060657
| Tradename: | PFIZERPEN |
| Applicant: | Pfizer |
| Ingredient: | penicillin g potassium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 060657
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PFIZERPEN | penicillin g potassium | INJECTABLE;INJECTION | 060657 | ANDA | Roerig | 0049-0420 | 0049-0420-10 | 10 VIAL in 1 CARTON (0049-0420-10) / 1 POWDER, FOR SOLUTION in 1 VIAL (0049-0420-05) |
| PFIZERPEN | penicillin g potassium | INJECTABLE;INJECTION | 060657 | ANDA | Roerig | 0049-0430 | 0049-0430-20 | 1 VIAL in 1 CARTON (0049-0430-20) / 1 POWDER, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5,000,000 UNITS/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20,000,000 UNITS/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
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