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Generated: May 25, 2019

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Details for New Drug Application (NDA): 076736

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NDA 076736 describes FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, which is a drug marketed by Baxter Hlthcare Corp, Fresenius Kabi Usa, Hikma Farmaceutica, Teva Pharms Usa, West-ward Pharms Int, Baxter Hlthcare, Hospira, Inforlife, Mylan Labs Ltd, Renaissance Ssa Llc, and Teva Pharms, and is included in fourteen NDAs. It is available from one supplier. Additional details are available on the FLUCONAZOLE IN SODIUM CHLORIDE 0.9% profile page.

The generic ingredient in FLUCONAZOLE IN SODIUM CHLORIDE 0.9% is fluconazole. There are twenty-three drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the fluconazole profile page.
Summary for 076736
Applicant:Hikma Farmaceutica
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076736
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% fluconazole INJECTABLE;INJECTION 076736 ANDA West-Ward Pharmaceuticals Corp 0143-9899 0143-9899-91 6 VIAL in 1 CARTON (0143-9899-91) > 100 mL in 1 VIAL (0143-9899-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:Aug 23, 2005TE:APRLD:No

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