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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 090582


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NDA 090582 describes NAFCILLIN SODIUM, which is a drug marketed by Antibiotice, Apothecon, Eugia Pharma Speclts, Fresenius, Istituto Bio Ita Spa, Sagent Pharms, Sandoz, Steriscience, 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 090582
Tradename:NAFCILLIN SODIUM
Applicant:Sagent Pharms
Ingredient:nafcillin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090582
Medical Subject Heading (MeSH) Categories for 090582
Suppliers and Packaging for NDA: 090582
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAFCILLIN SODIUM nafcillin sodium INJECTABLE;INJECTION 090582 ANDA Sagent Pharmaceuticals 25021-139 25021-139-10 10 VIAL in 1 CARTON (25021-139-10) / 4 mL in 1 VIAL
NAFCILLIN SODIUM nafcillin sodium INJECTABLE;INJECTION 090582 ANDA Sagent Pharmaceuticals 25021-140 25021-140-10 10 VIAL in 1 CARTON (25021-140-10) / 8 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Aug 24, 2012TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Aug 24, 2012TE:APRLD:No

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