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Details for New Drug Application (NDA): 061490

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NDA 061490 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: 061490

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

Pharmacology for NDA: 061490

Ingredient-typePenicillins

Suppliers and Packaging for NDA: 061490

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXACILLIN SODIUM
oxacillin sodium
INJECTABLE;INJECTION 061490 ANDA Sandoz Inc 0781-3099 0781-3099-95 10 VIAL in 1 PACKAGE (0781-3099-95) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3099-85)
OXACILLIN SODIUM
oxacillin sodium
INJECTABLE;INJECTION 061490 ANDA Sandoz Inc 0781-3101 0781-3101-95 10 VIAL in 1 PACKAGE (0781-3101-95) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3101-80)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes


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