Details for New Drug Application (NDA): 201538
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NDA 201538 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 six 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. Seven 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. Seven suppliers are listed for this compound. Additional details are available on the oxacillin sodium profile page.
Summary for 201538
| Tradename: | OXACILLIN SODIUM |
| Applicant: | Eugia Pharma Speclts |
| Ingredient: | oxacillin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 201538
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXACILLIN SODIUM | oxacillin sodium | INJECTABLE;INJECTION | 201538 | ANDA | Eugia US LLC | 55150-129 | 55150-129-99 | 1 VIAL, PHARMACY BULK PACKAGE in 1 BOX (55150-129-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10GM BASE/VIAL | ||||
| Approval Date: | Jan 18, 2013 | TE: | AP | RLD: | No | ||||
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