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Last Updated: August 11, 2020

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FLUCONAZOLE IN SODIUM CHLORIDE 0.9% Drug Profile

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When do Fluconazole In Sodium Chloride 0.9% patents expire, and when can generic versions of Fluconazole In Sodium Chloride 0.9% launch?

Fluconazole In Sodium Chloride 0.9% is a drug marketed by Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, West-ward Pharms Int, Baxter Hlthcare, Hospira, Inforlife, Mylan Labs Ltd, and Woodward. and is included in fourteen NDAs.

The generic ingredient in FLUCONAZOLE IN SODIUM CHLORIDE 0.9% is fluconazole. There are twenty-three drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

US ANDA Litigation and Generic Entry Outlook for Fluconazole In Sodium Chloride 0.9%

A generic version of FLUCONAZOLE IN SODIUM CHLORIDE 0.9% was approved as fluconazole by CHARTWELL on July 29th, 2004.

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Summary for FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
Drug patent expirations by year for FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
Recent Clinical Trials for FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Maimonides Medical CenterPhase 2
Hatem AbuHashimN/A
Shanghai Jiao Tong University School of MedicinePhase 2

See all FLUCONAZOLE IN SODIUM CHLORIDE 0.9% clinical trials

Pharmacology for FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

US Patents and Regulatory Information for FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Woodward FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 077909-001 May 26, 2010 AP RX No No   Start Trial   Start Trial   Start Trial
Woodward FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 077909-002 May 26, 2010 AP RX No No   Start Trial   Start Trial   Start Trial
Baxter Hlthcare Corp FLUCONAZOLE IN SODIUM CHLORIDE 0.9% fluconazole INJECTABLE;INJECTION 077947-001 May 26, 2010 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 076617-001 Jul 29, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 076889-002 Mar 25, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma Farmaceutica FLUCONAZOLE IN SODIUM CHLORIDE 0.9% fluconazole INJECTABLE;INJECTION 076736-001 Aug 23, 2005 AP RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys FLUCONAZOLE IN SODIUM CHLORIDE 0.9% fluconazole INJECTABLE;INJECTION 076653-002 Jul 29, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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