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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 Hikma Farmaceutica, Fresenius Kabi Usa, Claris, Teva Pharms Usa, Eurohlth Intl Sarl, Hospira, Acs Dobfar Info Sa, Teva Pharms, Baxter Hlthcare, and Mylan Labs Ltd, and is included in fourteen NDAs. It is available from two suppliers. 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. Forty-seven suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

Summary for NDA: 076736

Tradename:
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
Applicant:
Hikma Farmaceutica
Ingredient:
fluconazole
Patents:0
Therapeutic Class:Antifungals
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 Pharmaceutical Corp 0143-9899 0143-9899-91 6 VIAL in 1 CARTON (0143-9899-91) > 100 mL in 1 VIAL (0143-9899-01)

Summary 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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