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Details for New Drug Application (NDA): 091614

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NDA 091614 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: 091614

Tradename:
NAFCILLIN SODIUM
Applicant:
Aurobindo Pharma Ltd
Ingredient:
nafcillin sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 091614

Ingredient-typePenicillins

Suppliers and Packaging for NDA: 091614

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAFCILLIN SODIUM
nafcillin sodium
INJECTABLE;INJECTION 091614 ANDA AuroMedics Pharma LLC 55150-124 55150-124-09 1 VIAL, PHARMACY BULK PACKAGE in 1 BOX (55150-124-09) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
NAFCILLIN SODIUM
nafcillin sodium
INJECTABLE;INJECTION 091614 ANDA AuroMedics Pharma LLC 55150-124 55150-124-99 1 VIAL, PHARMACY BULK PACKAGE in 1 BOX (55150-124-99) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL
Approval Date:Dec 26, 2012TE:APRLD:No


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