Details for New Drug Application (NDA): 207148
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NDA 207148 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, Piramal Critical, Sagent Pharms, Sandoz, Steriscience Speclts, 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 are thirty-eight drug master file entries 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 are thirty-eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the oxacillin sodium profile page.
Summary for 207148
| Tradename: | OXACILLIN SODIUM |
| Applicant: | Wockhardt Bio Ag |
| Ingredient: | oxacillin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207148
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXACILLIN SODIUM | oxacillin sodium | INJECTABLE;INJECTION | 207148 | ANDA | Wockhardt USA LLC. | 64679-700 | 64679-700-01 | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (64679-700-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (64679-700-02) |
| OXACILLIN SODIUM | oxacillin sodium | INJECTABLE;INJECTION | 207148 | ANDA | Wockhardt USA LLC. | 64679-700 | 64679-700-03 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (64679-700-03) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (64679-700-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10GM BASE/VIAL | ||||
| Approval Date: | Nov 24, 2017 | TE: | AP | RLD: | No | ||||
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