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Generated: July 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077947

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NDA 077947 describes FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, which is a drug marketed by Hikma Farmaceutica, Fresenius Kabi Usa, Claris, Teva Pharms Usa, West-ward Pharms Int, 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. Fifty suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

Summary for NDA: 077947

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

Suppliers and Packaging for NDA: 077947

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
fluconazole
INJECTABLE;INJECTION 077947 ANDA Claris Lifesciences Inc. 36000-004 36000-004-06 6 VIAL, GLASS in 1 CARTON (36000-004-06) > 100 mL in 1 VIAL, GLASS
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
fluconazole
INJECTABLE;INJECTION 077947 ANDA Claris Lifesciences Inc. 36000-005 36000-005-06 6 VIAL, GLASS in 1 CARTON (36000-005-06) > 200 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:May 26, 2010TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength400MG/200ML (2MG/ML)
Approval Date:May 26, 2010TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
UBS
Teva
Colorcon
Cantor Fitzgerald
Accenture
Baxter
Harvard Business School
Medtronic
US Army

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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