For excessive sleepiness associated with obstructive sleep apnea (OSA). ANDA 200043, held by Mylan Pharms Inc. Armodafinil.
As of Nov 14, 2026, ANDA 200043 (Armodafinil), held by Mylan Pharms Inc, was first approved by FDA on May 9, 2019, with 3 approved supplements and 0 published complete response letters.
Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use In OSA, armodafinil 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 armodafinil tablets for excessive sleepiness.
| May 9, 2019 | Original application | Approved | None posted |
| Jun 1, 2012 | Original application | Approved |
| Armodafinil50MG · tablet;oral | Armodafinil | Rx |
| Armodafinil150MG · tablet;oral | Armodafinil | Rx |
| Armodafinil250MG · tablet;oral | Armodafinil | Rx |
| Armodafinil100MG · tablet;oral | Armodafinil | Rx |
| Armodafinil200MG · tablet;oral | Armodafinil | Rx |
| Dec 13, 2019 | Supplement 6Labeling · Standard review | Approved | None posted |
| May 9, 2019 | Original application | Approved | None posted |
| Jan 20, 2016 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 20, 2016 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jun 1, 2012 | Original application | Approved |
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
