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Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090002

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NDA 090002 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 eight 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. Nine suppliers are listed for this compound. Additional details are available on the nafcillin sodium profile page.
Summary for 090002
Tradename:NAFCILLIN SODIUM
Applicant:Istituto Bio Ita Spa
Ingredient:nafcillin sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 090002
Ingredient-typePenicillins
Medical Subject Heading (MeSH) Categories for 090002
Suppliers and Packaging for NDA: 090002
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAFCILLIN SODIUM nafcillin sodium INJECTABLE;INJECTION 090002 ANDA APP Pharmaceuticals, LLC 63323-327 E 63323-327-10
NAFCILLIN SODIUM nafcillin sodium INJECTABLE;INJECTION 090002 ANDA APP Pharmaceuticals, LLC 63323-328 E 63323-328-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Jun 30, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Jun 30, 2011TE:APRLD:No

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