Curious case of levamisole

[grishagin]

LEVAMISOLE HYDROCHLORIDE

DL9055K809

LEVAMISOLE

2880D3468G

These two pages are NOT linked:
https://drugs.ncats.io/drug/2880D3468G
https://drugs.ncats.io/drug/DL9055K809

Even though the correct parent is given as the active moiety in GSRS
https://ginas.ncats.nih.gov/ginas/app/substance/DL9055K809

For the hydrochloride, its 'approval' status is given via Pharm Manu Encycl:
https://stitcher.ncats.io/api/stitches/v1/DL9055K809

The parent page correctly lists approved NDA 20-035
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020035
{

• Comment: "Application:NDA020035 JANSSEN PHARMA https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020035",
• Year: "1990",
• created: 1534397662300,
• id: "2880D3468G",
• Approval: "Approval Year",
• Date Method: "Drugs@FDA",
• UNII: "2880D3468G",
• Date: "06/18/1990",
• source: "Drugs@FDA & OB, August 2018"

}

However, the status is given as 'Withdrawn'. I believe discontinued might be a more correct status for this drug in the US.

Searches online seem to indicate that it is only approved as a vet product, but in fact that vet product's approval was rescinded in 2010:
https://www.federalregister.gov/documents/2010/10/26/2010-27010/withdrawal-of-approval-of-new-animal-drug-applications-aklomide-levamisole-hydrochloride-nitromide