Details for New Drug Application (NDA): 065079
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The generic ingredient in PENICILLIN G POTASSIUM is penicillin g potassium. There are ninety-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the penicillin g potassium profile page.
Summary for 065079
Tradename: | PENICILLIN G POTASSIUM |
Applicant: | Sandoz |
Ingredient: | penicillin g potassium |
Patents: | 0 |
Suppliers and Packaging for NDA: 065079
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PENICILLIN G POTASSIUM | penicillin g potassium | INJECTABLE;INJECTION | 065079 | ANDA | Sandoz Inc | 0781-6135 | 0781-6135-95 | 10 VIAL in 1 CARTON (0781-6135-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-6135-94) |
PENICILLIN G POTASSIUM | penicillin g potassium | INJECTABLE;INJECTION | 065079 | ANDA | Sandoz Inc | 0781-6136 | 0781-6136-94 | 1 VIAL in 1 CARTON (0781-6136-94) / 1 INJECTION, 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| Strength | 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | Aug 30, 2002 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5,000,000 UNITS/VIAL | ||||
Approval Date: | Aug 30, 2002 | 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: | Aug 30, 2002 | TE: | AP | RLD: | No |
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