Details for New Drug Application (NDA): 091486
NDA 091486 describes OXACILLIN SODIUM, which is a drug marketed by Ani Pharms, Apothecon, Teva, Acs Dobfar Spa, Elkins Sinn, Eugia Pharma Speclts, Fresenius Kabi Usa, Hospira, 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 091486
| Tradename: | OXACILLIN SODIUM |
| Applicant: | Onesource Specialty |
| Ingredient: | oxacillin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091486
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXACILLIN SODIUM | oxacillin sodium | INJECTABLE;INJECTION | 091486 | ANDA | Armas Pharmaceuticals Inc. | 72485-409 | 72485-409-10 | 10 VIAL in 1 CARTON (72485-409-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-409-01) |
| OXACILLIN SODIUM | oxacillin sodium | INJECTABLE;INJECTION | 091486 | ANDA | Onesource Specialty Pharma Limited | 83270-306 | 83270-306-10 | 10 VIAL in 1 CARTON (83270-306-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Aug 25, 2014 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | Aug 25, 2014 | TE: | AP | RLD: | No | ||||
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