Ivan Grishagin
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...
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...
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...
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should supercede any other 'withdrawn' list in the US.
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...
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:...
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...
Withdrawns:-- what does the year mean?-- improve the source shown in the Source URL-- are they really all withdrawn?
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