Orange Book product · Brand (NDA)
NUVIGIL
ARMODAFINIL
At a glance
Jun 15, 2007
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 15, 2007
19 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
ARMODAFINIL
Strength
50MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021875
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2019ARMODAFINILGeneric (ANDA)
ANDA 201514 · COREPHARMA
- 2018ARMODAFINILGeneric (ANDA)
ANDA 206069 · AUROBINDO PHARMA LTD
- 2016ARMODAFINILGeneric (ANDA)
ANDA 200751 · LUPIN
- 2016ARMODAFINILGeneric (ANDA)
ANDA 202768 · NATCO PHARMA LTD
- 2012ARMODAFINILGeneric (ANDA)
ANDA 200156 · WATSON LABS INC
- 2012ARMODAFINILGeneric (ANDA)
ANDA 200043 · MYLAN PHARMS INC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
