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Generated: December 15, 2017

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 NDAs. It is available from five 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. Six suppliers are listed for this compound. Additional details are available on the oxacillin sodium profile page.

Summary for 201539

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

Pharmacology for NDA: 201539

Ingredient-typePenicillins

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 55150-127-15 10 VIAL in 1 BOX (55150-127-15) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
OXACILLIN SODIUM oxacillin sodium INJECTABLE;INJECTION 201539 ANDA AuroMedics Pharma LLC 55150-128 55150-128-25 10 VIAL in 1 BOX (55150-128-25) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Jan 18, 2013TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Jan 18, 2013TE:APRLD:No


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