A plain-language guide Approval

FDA approval

What approval means, and why a product code is different.

The Food and Drug Administration uses the short name FDA. It reviews medicines as a U.S. agency.

FDA approval tells you that a particular medicine has been reviewed by the agency for a stated use.

Selank has no U.S. approval and no official U.S. drug label.

A government product code is not approval

A product’s National Drug Code, or NDC, is its identifier in a government list.

A product code does not mean FDA has approved the medicine.

The Selank products listed there are powders used to make medicines, rather than medicines ready for a patient.

The maker’s leaflet says Russia once gave permission to sell Selank as an anxiety medicine.

This guide’s sources could not confirm whether that permission still applies.

That Russian permission does not give Selank U.S. approval.

Does “approved” refer to this finished medicine in this country, or does it refer to a listing, an ingredient, or a past event?

FDA: Selank approval search
The U.S. approval and product listings were checked on September 30, 2026.
FDA: what a drug code means
The meaning of a product code was checked on September 26, 2026.
Russia: the maker’s leaflet
The Russian permission could not be confirmed as still in force on September 30, 2026.