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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200002

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NDA 200002 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 200002

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 200002

Ingredient-typePenicillins

Medical Subject Heading (MeSH) Categories for 200002

Suppliers and Packaging for NDA: 200002

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAFCILLIN SODIUM nafcillin sodium INJECTABLE;INJECTION 200002 ANDA Teva Parenteral Medicines, Inc. 0703-9095 0703-9095-03 10 VIAL in 1 CARTON (0703-9095-03) > 4 mL in 1 VIAL (0703-9095-01)
NAFCILLIN SODIUM nafcillin sodium INJECTABLE;INJECTION 200002 ANDA Teva Parenteral Medicines, Inc. 0703-9105 0703-9105-03 10 VIAL in 1 CARTON (0703-9105-03) > 8 mL in 1 VIAL (0703-9105-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Apr 7, 2014TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Apr 7, 2014TE:APRLD:No


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