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Last Updated: April 15, 2021

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Sodium chloride - Generic Drug Details

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What are the generic sources for sodium chloride and what is the scope of freedom to operate?

Sodium chloride is the generic ingredient in thirteen branded drugs marketed by Blairex, Abraxis Pharm, Fresenius Kabi Usa, Hospira, Abbott, B Braun, Baxter Hlthcare, Icu Medical Inc, Miles, Medefil Inc, Spectra Mdcl Devices, West-ward Pharms Int, Fresenius Medcl, Haemonetics, Jubilant Cadista, Laboratorios Grifols, Liebel-flarsheim, Nephron, and Taro, and is included in fifty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are one thousand four hundred and seventy-two drug master file entries for sodium chloride. Twenty-two suppliers are listed for this compound.

Summary for sodium chloride
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US Patents and Regulatory Information for sodium chloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride SOLUTION;IRRIGATION 018380-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Medefil Inc SODIUM CHLORIDE 0.9% sodium chloride INJECTABLE;INJECTION 202832-002 Jan 6, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
West-ward Pharms Int SODIUM CHLORIDE 0.9% sodium chloride INJECTABLE;INJECTION 201850-001 Jan 20, 2012 AP RX No No   Start Trial   Start Trial   Start Trial
Baxter Hlthcare SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride SOLUTION;IRRIGATION 017427-001 Approved Prior to Jan 1, 1982 AT RX No No   Start Trial   Start Trial   Start Trial
Baxter Hlthcare SODIUM CHLORIDE 5% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 019022-002 Nov 1, 1983 AP RX Yes No   Start Trial   Start Trial   Start Trial
Laboratorios Grifols SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 207956-001 May 25, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Haemonetics SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 076316-001 Oct 27, 2004 AP RX 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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