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Details for New Drug Application (NDA): 200002

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NDA 200002 describes NAFCILLIN SODIUM, which is a drug marketed by Istituto Bio Ita Spa, Mylan Labs Ltd, Watson Labs Inc, Aurobindo Pharma Ltd, Sandoz, Antibiotice, Sagent Pharms, and Apothecon, and is included in thirteen NDAs. It is available from seven suppliers. Additional details are available on the NAFCILLIN SODIUM profile page.

The generic ingredient in NAFCILLIN SODIUM is nafcillin sodium. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the nafcillin sodium profile page.

Summary for NDA: 200002

Mylan Labs Ltd
nafcillin sodium
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 200002


Suppliers and Packaging for NDA: 200002

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
nafcillin sodium
INJECTABLE;INJECTION 200002 ANDA Teva Parenteral Medicines, Inc. 0703-9095 0703-9095-03 10 VIAL in 1 CARTON (0703-9095-03) > 4 mL in 1 VIAL (0703-9095-01)
nafcillin sodium
INJECTABLE;INJECTION 200002 ANDA Teva Parenteral Medicines, Inc. 0703-9105 0703-9105-03 10 VIAL in 1 CARTON (0703-9105-03) > 8 mL in 1 VIAL (0703-9105-01)

Summary for product number 001

Approval Date:Apr 7, 2014TE:APRLD:No

Summary for product number 002

Approval Date:Apr 7, 2014TE:APRLD:No

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