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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 090580


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NDA 090580 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.
Summary for 090580
Tradename:NAFCILLIN SODIUM
Applicant:Sagent Pharms
Ingredient:nafcillin sodium
Patents:0
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

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL
Approval Date:Aug 24, 2012TE:APRLD:No

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