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Details for New Drug Application (NDA): 203950

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NDA 203950 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: 203950

Hospira Inc
oxacillin sodium
Therapeutic Class:Antibacterials

Pharmacology for NDA: 203950


Suppliers and Packaging for NDA: 203950

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
oxacillin sodium
INJECTABLE;INJECTION 203950 ANDA Hospira, Inc. 0409-1230 0409-1230-01 25 VIAL in 1 CARTON (0409-1230-01) > 1 POWDER, FOR SOLUTION in 1 VIAL (0409-1230-11)
oxacillin sodium
INJECTABLE;INJECTION 203950 ANDA Hospira, Inc. 0409-1231 0409-1231-01 25 VIAL in 1 CARTON (0409-1231-01) > 1 POWDER, FOR SOLUTION in 1 VIAL (0409-1231-11)

Summary for product number 001

Approval Date:Dec 11, 2015TE:APRLD:No

Summary for product number 002

Approval Date:Dec 11, 2015TE:APRLD:No

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