Details for New Drug Application (NDA): 065448
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NDA 065448 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 six 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. Eight 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. Eight suppliers are listed for this compound. Additional details are available on the penicillin g potassium profile page.
Summary for 065448
| Tradename: | PENICILLIN G POTASSIUM |
| Applicant: | Istituto Bio Ita Spa |
| Ingredient: | penicillin g potassium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065448
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PENICILLIN G POTASSIUM | penicillin g potassium | INJECTABLE;INJECTION | 065448 | ANDA | Sagent Pharmaceuticals | 25021-154 | 25021-154-51 | 1 VIAL in 1 CARTON (25021-154-51) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| PENICILLIN G POTASSIUM | penicillin g potassium | INJECTABLE;INJECTION | 065448 | ANDA | Athenex Pharmaceutical Division, LLC. | 70860-126 | 70860-126-20 | 10 VIAL in 1 CARTON (70860-126-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70860-126-41) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5,000,000 UNITS/VIAL | ||||
| Approval Date: | Aug 18, 2009 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20,000,000 UNITS/VIAL | ||||
| Approval Date: | Aug 18, 2009 | TE: | AP | RLD: | No | ||||
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