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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Federal Trade Commission
Cantor Fitzgerald

Generated: July 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201539

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NDA 201539 describes OXACILLIN SODIUM, which is a drug marketed by Ani Pharms Inc, Apothecon, Teva, Aurobindo Pharma Ltd, Elkins Sinn, Hospira Inc, Istituto Bio Ita Spa, Mylan Labs Ltd, Renaissance Ssa Llc, Sagent Pharms, Sandoz, Watson Labs Inc, and Wockhardt Bio Ag, and is included in twenty-one NDAs. It is available from six suppliers. Additional details are available on the OXACILLIN SODIUM profile page.

The generic ingredient in OXACILLIN SODIUM is oxacillin sodium. There are thirty-eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the oxacillin sodium profile page.
Summary for 201539
Applicant:Aurobindo Pharma Ltd
Ingredient:oxacillin sodium
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 201539
Medical Subject Heading (MeSH) Categories for 201539
Suppliers and Packaging for NDA: 201539
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXACILLIN SODIUM oxacillin sodium INJECTABLE;INJECTION 201539 ANDA AuroMedics Pharma LLC 55150-127 N 55150-127-15
OXACILLIN SODIUM oxacillin sodium INJECTABLE;INJECTION 201539 ANDA AuroMedics Pharma LLC 55150-128 N 55150-128-25

Profile for product number 001

Approval Date:Jan 18, 2013TE:APRLD:No

Profile for product number 002

Approval Date:Jan 18, 2013TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Express Scripts
US Department of Justice
Queensland Health
Cantor Fitzgerald
Johnson and Johnson

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