Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Farmers Insurance
Chinese Patent Office
Harvard Business School
Boehringer Ingelheim

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091614

« Back to Dashboard

NDA 091614 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 six 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. Seven suppliers are listed for this compound. Additional details are available on the nafcillin sodium profile page.
Summary for 091614
Applicant:Aurobindo Pharma Ltd
Ingredient:nafcillin sodium
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 091614
Medical Subject Heading (MeSH) Categories for 091614
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 N 55150-124-09
NAFCILLIN SODIUM nafcillin sodium INJECTABLE;INJECTION 091614 ANDA AuroMedics Pharma LLC 55150-124 N 55150-124-99

Profile for product number 001

Approval Date:Dec 26, 2012TE:APRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.