Armodafinil

ANDA 200156, held by Watson Labs Inc. Armodafinil.

As of Nov 14, 2026, ANDA 200156 (Armodafinil), held by Watson Labs Inc, was first approved by FDA on Aug 29, 2012, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 29, 2012
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

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


Aug 29, 2012	Original application	Approved	Letter
Aug 29, 2012	Original application	Tentative approval	None posted

Products

5 strengths and forms


Armodafinil50MG · tablet; oral	Armodafinil	None (tentative approval)
Armodafinil100MG · tablet;oral	Armodafinil	Discontinued
Armodafinil150MG · tablet; oral	Armodafinil	None (tentative approval)
Armodafinil200MG · tablet;oral	Armodafinil	Discontinued
Armodafinil2500MG · tablet; oral	Armodafinil	None (tentative approval)

All 3 submissions, including labeling and manufacturing supplements


Jan 25, 2017	Supplement 1Labeling · Standard review	Approved	None posted
Aug 29, 2012	Original application	Approved	Letter
Aug 29, 2012	Original application	Tentative approval	None posted

Identifiers

Application: ANDA 200156
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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