For excessive sleepiness associated with narcolepsy. ANDA 202566, held by Aurobindo Pharma Ltd. Modafinil.
As of Nov 15, 2026, ANDA 202566 (Modafinil), held by Aurobindo Pharma Ltd, was first approved by FDA on Sep 27, 2012, with 2 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 27, 2012 | Original application | Approved | None posted |
| Dec 18, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 5, 2014 | Supplement 3Manufacturing | Approved | None posted |
| Sep 27, 2012 | Original application | Approved | None posted |
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
