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Generated: April 28, 2017

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Details for New Drug Application (NDA): 090005

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NDA 090005 describes NAFCILLIN SODIUM, which is a drug marketed by Istituto Bio Ita Spa, Mylan Labs Ltd, Watson Labs Inc, Aurobindo Pharma Ltd, Sandoz, Antibiotice, Sagent Pharms, and Apothecon, and is included in thirteen NDAs. It is available from seven 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. Eight suppliers are listed for this compound. Additional details are available on the nafcillin sodium profile page.

Summary for NDA: 090005

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 090005


Suppliers and Packaging for NDA: 090005

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
INJECTABLE;INJECTION 090005 ANDA APP Pharmaceuticals, 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

Summary for product number 001

Approval Date:Apr 20, 2011TE:APRLD:No

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