Details for New Drug Application (NDA): 091613
✉ Email this page to a colleague
NDA 091613 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 091613
| Tradename: | NAFCILLIN SODIUM |
| Applicant: | Eugia Pharma Speclts |
| Ingredient: | nafcillin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091613
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NAFCILLIN SODIUM | nafcillin sodium | INJECTABLE;INJECTION | 091613 | ANDA | Eugia US LLC | 55150-122 | 55150-122-15 | 10 VIAL in 1 BOX (55150-122-15) / 4 mL in 1 VIAL |
| NAFCILLIN SODIUM | nafcillin sodium | INJECTABLE;INJECTION | 091613 | ANDA | Eugia US LLC | 55150-123 | 55150-123-15 | 10 VIAL in 1 BOX (55150-123-15) / 8 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Dec 26, 2012 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | Dec 26, 2012 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
