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Last Updated: March 19, 2024

Sodium lactate - Generic Drug Details


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

Sodium lactate is the generic ingredient in three branded drugs marketed by B Braun, Baxter Hlthcare, and Hospira, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for sodium lactate.

Recent Clinical Trials for sodium lactate

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

SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 4
Emory UniversityPhase 4
Makerere UniversityPhase 4

See all sodium lactate clinical trials

US Patents and Regulatory Information for sodium lactate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER sodium lactate INJECTABLE;INJECTION 016692-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
B Braun SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER sodium lactate INJECTABLE;INJECTION 018186-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira SODIUM LACTATE IN PLASTIC CONTAINER sodium lactate INJECTABLE;INJECTION 018947-001 Sep 5, 1984 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
B Braun SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER sodium lactate INJECTABLE;INJECTION 020004-001 Apr 21, 1992 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER sodium lactate INJECTABLE;INJECTION 018249-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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