Modafinil

For excessive sleepiness associated with narcolepsy. ANDA 202700, held by Alembic. Modafinil.

As of Nov 15, 2026, ANDA 202700 (Modafinil), held by Alembic, was first approved by FDA on Oct 18, 2012, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 18, 2012
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Oct 18, 2012	Original application	Approved	None posted

Products

2 strengths and forms


Modafinil100MG · tablet;oral	Modafinil	Rx
Modafinil200MG · tablet;oral	Modafinil	Rx

All 2 submissions, including labeling and manufacturing supplements


Jun 15, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Oct 18, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 202700
Drugs@FDA: Overview at FDA
Company: Alembic, LLC

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