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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091246

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NDA 091246 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 091246

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

Pharmacology for NDA: 091246

Ingredient-typePenicillins

Medical Subject Heading (MeSH) Categories for 091246

Suppliers and Packaging for NDA: 091246

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXACILLIN SODIUM oxacillin sodium INJECTABLE;INJECTION 091246 ANDA Sagent Pharmaceuticals 25021-146 25021-146-10 10 VIAL in 1 CARTON (25021-146-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
OXACILLIN SODIUM oxacillin sodium INJECTABLE;INJECTION 091246 ANDA Sagent Pharmaceuticals 25021-146 25021-146-66 10 VIAL in 1 CARTON (25021-146-66) > 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:Mar 30, 2012TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Mar 30, 2012TE:APRLD:No


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