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Generated: October 21, 2018

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Details for New Drug Application (NDA): 090580

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NDA 090580 describes NAFCILLIN SODIUM, which is a drug marketed by Antibiotice, Apothecon, Aurobindo Pharma Ltd, Istituto Bio Ita Spa, Mylan Labs Ltd, Sagent Pharms, Sandoz, and Watson Labs Inc, and is included in thirteen 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.
Summary for 090580
Applicant:Sagent Pharms
Ingredient:nafcillin sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 090580
Medical Subject Heading (MeSH) Categories for 090580
Suppliers and Packaging for NDA: 090580
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAFCILLIN SODIUM nafcillin sodium INJECTABLE;INJECTION 090580 ANDA Sagent Pharmaceuticals 25021-141 25021-141-99 10 BOTTLE in 1 CARTON (25021-141-99) > 100 mL in 1 BOTTLE

Profile for product number 001

Approval Date:Aug 24, 2012TE:APRLD:No

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