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Details for New Drug Application (NDA): 091245

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NDA 091245 describes OXACILLIN SODIUM, which is a drug marketed by Elkins Sinn, Ani Pharms Inc, Sandoz, Aurobindo Pharma Ltd, Sagent Pharms, Apothecon, Hospira Inc, Teva, Watson Labs Inc, Mylan Labs Ltd, and Istituto Bio Ita Spa, and is included in seventeen 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 NDA: 091245

Tradename:
OXACILLIN SODIUM
Applicant:
Sagent Pharms
Ingredient:
oxacillin sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 091245

Ingredient-typePenicillins

Suppliers and Packaging for NDA: 091245

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXACILLIN SODIUM
oxacillin sodium
INJECTABLE;INJECTION 091245 ANDA Sagent Pharmaceuticals 25021-163 25021-163-69 10 BOTTLE in 1 CARTON (25021-163-69) > 100 mL in 1 BOTTLE
OXACILLIN SODIUM
oxacillin sodium
INJECTABLE;INJECTION 091245 ANDA Sagent Pharmaceuticals 25021-163 25021-163-99 10 BOTTLE in 1 CARTON (25021-163-99) > 100 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL
Approval Date:Mar 30, 2012TE:APRLD:No


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