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Details for New Drug Application (NDA): 091486

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NDA 091486 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: 091486

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

Pharmacology for NDA: 091486

Ingredient-typePenicillins

Suppliers and Packaging for NDA: 091486

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXACILLIN SODIUM
oxacillin sodium
INJECTABLE;INJECTION 091486 ANDA Teva Parenteral Medicines, Inc. 0703-9106 0703-9106-03 10 VIAL in 1 CARTON (0703-9106-03) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
OXACILLIN SODIUM
oxacillin sodium
INJECTABLE;INJECTION 091486 ANDA Teva Parenteral Medicines, Inc. 0703-9107 0703-9107-03 10 VIAL in 1 CARTON (0703-9107-03) > 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:Aug 25, 2014TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Aug 25, 2014TE:APRLD:No


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