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Amend 8 to License 24-04206-05MD for Mallinckrodt,Inc, amending license in entirety.

Accession Number: ML20150F580

Date Released: Monday, October 28, 2024

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• ML20210M826 - Forwards Amend 8 to License 24-04206-05MD.Record of 850816 telcon encl. (7 page(s), 8/16/1985)
• ML20210M840 - Provides suggestion for remedying common problem in radiopharm industry re shipping of Mo-99/Tc-99m generators w/calibr dates 4 to 7 days beyond date of receipt by user. (3 page(s), 3/28/1975)
• ML20210M847 - Requests addl info re 800226 application for renewal of License 24-04206-05MD.FDA ltr indicating approval of NDA for each product should be submitted. (3 page(s), 7/19/1983)
• ML20210M857 - Responds to 841130 request for addl info re application for renewal of License 24-04206-05MD.Info re exposure levels at surface of vial shields & advance calibr of radiopharms prior to shipment to group licensees provided. (10 page(s), 1/18/1985)
• ML20210M873 - Requests addl info to support application for distribution license.Samples of package inserts & labels for all products requesting licensure or approval requested. (2 page(s), 11/8/1974)
• ML20210M877 - Responds to 741108 request for addl info re application for distribution license.Sample copies of package inserts & labels for all products included in original application encl.W/o encl. (2 page(s), 12/5/1974)
• ML20210M893 - Forwards License 24-04206-05MD,authorizing distribution of byproduct matls &/or Mo-99/Tc-99m generators to persons licensed,per Sections 35.14 & 35.100 of 10CFR35. (1 page(s), 1/6/1975)
• ML20210Q383 - Trip rept of attendance at 750227 meeting w/radiopharm mfgs representatives in Bethesda,MD re proposed labeling changes under group licensing. (2 page(s), 2/27/1975)
• ML20210M948 - Summary of 750227 meeting w/AIF re plans for implementing change in assay procedures for Mo-99/Tc-99m generators & radiopharms.List of participants encl. (3 page(s), 3/6/1975)
• ML20210N143 - Forwards notice mailed to all medical licensees & 750328 ltr mailed to AIF.All distributors applying for renewal of license for distribution of Mo-99/Tc 99m generators will be required to submit evidence of compliance w/new procedures. (1 page(s), 4/16/1975)
• ML20210N194 - Discusses practice by radiopharm industry re shipment of Mo-99/Tc-99m generators w/calibr dates 4-7 days beyond date of user receipt.Labeling procedures defined. (1 page(s), 3/28/1975)
• ML20210N251 - Requests addl info re 750228 application for renewal of License 24-04206-05MD.Description of methods for meeting labeling criteria specified in NRC 750328 ltr requested. (1 page(s), 6/19/1975)
• ML20210N312 - Responds to 750619 request for description of methods used to meet labeling criteria specified in NRC 750328 ltr. Changes to labeling of Ultra-Technekow/Ultra-Technekow FM Tc-99m generators will be in effect during wk of 750804. (5 page(s), 7/8/1975)
• ML20210N345 - Requests that application for renewal of License 24-04206-05MD be considered & approved w/o imposition of requirements for calibr stated in Paragraph 4 of 750328 ltr. Supporting documentation encl. (117 page(s), 8/5/1975)
• ML20210N781 - Discusses application for renewal of License 29-00139-04MD & 810408 & 0625 telcons.Shielding provided for products not sufficient for safe handling & storage by group medical licensees. (2 page(s), 7/15/1981)
• ML20210N848 - Forwards max radiation levels for surface of shielded radiopharm vials supplied by ER Squibb & Sons,for review. (1 page(s), 2/10/1981)
• ML20150F658 - Ack receipt of application for renewal of License 24-04206-05MD. (1 page(s), 4/17/1980)
• ML20210P048 - Requests fee for 800226 application for renewal of License 24-04206-05MD. (1 page(s), 3/11/1980)
• ML20210P120 - Remits fee for 800226 application for renewal of License 24-04206-05MD. (1 page(s), 4/3/1980)
• ML20150F575 - Application for renewal of License 24-04206-05MD,authorizing mfg & distribution of generators & radiopharms containing Groups I-V matls.Fee paid. (100 page(s), 2/26/1980)