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Last Updated: August 3, 2020

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Edetate calcium disodium - Generic Drug Details

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What are the generic drug sources for edetate calcium disodium and what is the scope of freedom to operate?

Edetate calcium disodium is the generic ingredient in one branded drug marketed by Medicis and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for edetate calcium disodium.

Summary for edetate calcium disodium
Recent Clinical Trials for edetate calcium disodium

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

SponsorPhase
National Cancer Institute (NCI)Phase 2
M.D. Anderson Cancer CenterPhase 2
Mt. Sinai Medical Center, MiamiPhase 4

See all edetate calcium disodium clinical trials

US Patents and Regulatory Information for edetate calcium disodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medicis CALCIUM DISODIUM VERSENATE edetate calcium disodium TABLET;ORAL 008922-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Medicis CALCIUM DISODIUM VERSENATE edetate calcium disodium INJECTABLE;INJECTION 008922-001 Approved Prior to Jan 1, 1982 RX Yes Yes   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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Serving leading biopharmaceutical companies globally:

Baxter
Dow
Merck
Johnson and Johnson
Mallinckrodt
Medtronic

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