Details for New Drug Application (NDA): 090005
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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 090005
Tradename: | NAFCILLIN SODIUM |
Applicant: | Istituto Bio Ita Spa |
Ingredient: | nafcillin sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 090005
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAFCILLIN SODIUM | nafcillin sodium | INJECTABLE;INJECTION | 090005 | ANDA | WG Critical Care, LLC | 44567-223 | 44567-223-01 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (44567-223-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
NAFCILLIN SODIUM | nafcillin sodium | INJECTABLE;INJECTION | 090005 | ANDA | Fresenius Kabi USA, LLC | 63323-330 | 63323-330-60 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-330-60) / 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: | Apr 20, 2011 | TE: | AP | RLD: | No |
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