Orange Book product · Brand (NDA)
PROVIGIL
MODAFINIL
At a glance
Dec 24, 1998
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 24, 1998
27 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
MODAFINIL
Strength
100MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020717
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.
- 2017MODAFINILGeneric (ANDA)
ANDA 209966 · CADILA
- 2017MODAFINILGeneric (ANDA)
ANDA 207196 · APPCO
- 2014MODAFINILGeneric (ANDA)
ANDA 077667 · APOTEX
- 2012MODAFINILGeneric (ANDA)
ANDA 076715 · WATSON LABS INC
- 2012MODAFINILGeneric (ANDA)
ANDA 202700 · ALEMBIC
- 2012MODAFINILGeneric (ANDA)
ANDA 202566 · AUROBINDO PHARMA LTD
- 2012MODAFINILGeneric (ANDA)
ANDA 090543 · HIKMA PHARMS
- 2012MODAFINILGeneric (ANDA)
ANDA 078963 · ORBION PHARMS
- 2012MODAFINILGeneric (ANDA)
ANDA 076594 · NATCO PHARMA
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.
