Details for New Drug Application (NDA): 090002
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NDA 090002 describes NAFCILLIN SODIUM, which is a drug marketed by Antibiotice, Apothecon, Eugia Pharma Speclts, Fresenius, Istituto Bio Ita Spa, Sagent Pharms, Sandoz, Steriscience Speclts, and Watson Labs Inc, and is included in fifteen NDAs. It is available from nine suppliers. Additional details are available on the NAFCILLIN SODIUM profile page.
The generic ingredient in NAFCILLIN SODIUM is nafcillin sodium. There are eleven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the nafcillin sodium profile page.
The generic ingredient in NAFCILLIN SODIUM is nafcillin sodium. There are eleven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the nafcillin sodium profile page.
Summary for 090002
| Tradename: | NAFCILLIN SODIUM |
| Applicant: | Istituto Bio Ita Spa |
| Ingredient: | nafcillin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090002
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NAFCILLIN SODIUM | nafcillin sodium | INJECTABLE;INJECTION | 090002 | ANDA | Fresenius Kabi USA, LLC | 63323-327 | 63323-327-10 | 10 VIAL in 1 CARTON (63323-327-10) / 4 mL in 1 VIAL (63323-327-21) |
| NAFCILLIN SODIUM | nafcillin sodium | INJECTABLE;INJECTION | 090002 | ANDA | Fresenius Kabi USA, LLC | 63323-328 | 63323-328-20 | 10 VIAL in 1 CARTON (63323-328-20) / 8 mL in 1 VIAL (63323-328-21) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Jun 30, 2011 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | Jun 30, 2011 | TE: | AP | RLD: | No | ||||
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