Details for New Drug Application (NDA): 206198
✉ Email this page to a colleague
NDA 206198 describes OXACILLIN SODIUM, which is a drug marketed by Ani Pharms, Apothecon, Teva, Elkins Sinn, Eugia Pharma Speclts, Fresenius Kabi Usa, Hospira, Istituto Bio Ita Spa, Onesource Specialty, Piramal Critical, Sagent Pharms, Sandoz, Watson Labs Inc, and Wockhardt Bio Ag, and is included in twenty-three NDAs. It is available from five suppliers. Additional details are available on the OXACILLIN SODIUM profile page.
The generic ingredient in OXACILLIN SODIUM is oxacillin sodium. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the oxacillin sodium profile page.
The generic ingredient in OXACILLIN SODIUM is oxacillin sodium. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the oxacillin sodium profile page.
Summary for 206198
| Tradename: | OXACILLIN SODIUM |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | oxacillin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206198
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXACILLIN SODIUM | oxacillin sodium | INJECTABLE;INJECTION | 206198 | ANDA | Fresenius Kabi USA, LLC | 63323-812 | 63323-812-20 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-812-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-812-01) |
| OXACILLIN SODIUM | oxacillin sodium | INJECTABLE;INJECTION | 206198 | ANDA | Fresenius Kabi USA, LLC | 63323-813 | 63323-813-20 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-813-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-813-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Jul 20, 2020 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | Jul 20, 2020 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
