Details for New Drug Application (NDA): 065079
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NDA 065079 describes PENICILLIN G POTASSIUM, which is a drug marketed by Mylan, Purepac Pharm, Acs Dobfar Spa, Apothecon, Consolidated Pharm, Hq Speclt Pharma, Istituto Bio Ita Spa, Lilly, Parke Davis, Pfizer, Sandoz, Watson Labs Inc, Ivax Sub Teva Pharms, Teva, Wyeth Ayerst, and Baxter Hlthcare, and is included in twenty-one NDAs. It is available from five suppliers. Additional details are available on the PENICILLIN G POTASSIUM profile page.
The generic ingredient in PENICILLIN G POTASSIUM is penicillin g potassium. There are ninety-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the penicillin g potassium profile page.
The generic ingredient in PENICILLIN G POTASSIUM is penicillin g potassium. There are ninety-two drug master file entries for this compound. Seven 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| Strength | 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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