Thalidomide

ANDA 213267, held by Natco. Thalidomide.

As of Nov 15, 2026, ANDA 213267 (Thalidomide), held by Natco, was first approved by FDA on Apr 24, 2026, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 24, 2026
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below


Apr 24, 2026	Original application	Approved	None posted
Apr 27, 2023	Original application	Approved	Letter REMS

Products

4 strengths and forms


Thalidomide150MG · capsule;oral	Thalidomide	Discontinued
Thalidomide50MG · capsule;oral	Thalidomide	Rx
Thalidomide100MG · capsule;oral	Thalidomide	Rx
Thalidomide200MG · capsule;oral	Thalidomide	Rx

All 3 submissions, including labeling and manufacturing supplements


Sep 2, 2026	Supplement 2REMS	Approved	None posted
Apr 24, 2026	Original application	Approved	None posted
Apr 27, 2023	Original application	Approved	Letter REMS

Identifiers

Application: ANDA 213267
Drugs@FDA: Overview at FDA
Company: Natco Corp.

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters