Ivan Grishagin

Results 77 issues of Ivan Grishagin

Many SPL labels include ingredients other than active ingredients. While we can't transfer the legal auth to these additional ingredients, e.g. “OTC monograph final part333D" - we should index them...

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We already have some coverage of pesticides via the EPA Pesticide classification data from substances, e.g.:https://drugs.ncats.io/drug/JCS58I644WIt would be good to pull this group out and put a higher-level tag on...

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LEVAMISOLE HYDROCHLORIDEDL9055K809LEVAMISOLE 2880D3468GThese two pages are NOT linked:https://drugs.ncats.io/drug/2880D3468Ghttps://drugs.ncats.io/drug/DL9055K809Even though the correct parent is given as the active moiety in GSRShttps://ginas.ncats.nih.gov/ginas/app/substance/DL9055K809For the hydrochloride, its 'approval' status is given via Pharm Manu...

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https://www.gpo.gov/fdsys/pkg/CFR-2018-title21-vol4/xml/CFR-2018-title21-vol4-sec216-24.xmlThis should supercede any other 'withdrawn' list in the US.

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The drug is listed in GSRS, but appears to be missing from drugs.ncats.io --- was FDA approved via BLA in 2018Oops .. apparently is was approved in 1991https://en.wikipedia.org/wiki/Granulocyte-macrophage_colony-stimulating_factorAlso missing Molgramostimhttps://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/UCM578137.pdfAlso...

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Curious Case of Adenine

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Parsed SPL entry for SR60A3XG0F is: SR60A3XG0F BLA STANDARDIZED ALLERGENIC 2013-06-01 1994 ACTIB BLA103738 [NDC would have been here] "CINNAMALDEHYDE" "STANDARDIZED ALLERGENIC" https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f082b68-dc74-418a-9e6f-b3c285b41d44However, the NDC for this product does exist:...

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CALCIUM CATION 2M83C4R6ZB Status: US Approved OTC First Approved: 1941 1941 is not found in the cited label. SPL problem? { kind: "USApprovalRx", source: "spl_acti_rx.txt", id: "NDC 63323-360", product: "CALCIUM...

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Withdrawns:-- what does the year mean?-- improve the source shown in the Source URL-- are they really all withdrawn?

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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=001504NDA 1-504 Original 1939 approval letter:https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/001504Orig1s000.pdf1941 JAMA article saying that the product was removed from the market:https://archive.org/details/in.ernet.dli.2015.116204?q=%22verard+solution%22

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