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Generated: October 18, 2017

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Details for New Drug Application (NDA): 201539

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NDA 201539 describes OXACILLIN SODIUM, which is a drug marketed by Elkins Sinn, Ani Pharms Inc, Sandoz, Aurobindo Pharma Ltd, Sagent Pharms, Wockhardt Bio Ag, Apothecon, Hospira Inc, Teva, Watson Labs Inc, Renaissance Ssa Llc, Mylan Labs Ltd, and Istituto Bio Ita Spa, and is included in nineteen NDAs. It is available from four 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. Five suppliers are listed for this compound. Additional details are available on the oxacillin sodium profile page.

Summary for NDA: 201539

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

Pharmacology for NDA: 201539

Ingredient-typePenicillins

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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