Armodafinil

ANDA 200751, held by Lupin. Armodafinil.

As of Nov 14, 2026, ANDA 200751 (Armodafinil), held by Lupin, was first approved by FDA on Nov 28, 2016, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 28, 2016
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below


Nov 28, 2016	Original application	Approved	None posted
Nov 28, 2016	Original application	Tentative approval	None posted

Products

5 strengths and forms


Armodafinil50MG · tablet;oral	Armodafinil	Discontinued
Armodafinil100MG · tablet; oral	Armodafinil	None (tentative approval)
Armodafinil150MG · tablet;oral	Armodafinil	Discontinued
Armodafinil200MG · tablet;oral	Armodafinil	Discontinued
Armodafinil250MG · tablet;oral	Armodafinil	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jul 14, 2017	Supplement 2Labeling · Standard review	Approved	None posted
Jul 14, 2017	Supplement 3Manufacturing	Approved	None posted
Nov 28, 2016	Original application	Approved	None posted
Nov 28, 2016	Original application	Tentative approval	None posted

Identifiers

Application: ANDA 200751
Drugs@FDA: Overview at FDA
Company: Lupin

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