Orange Book product · Generic (ANDA)
MODAFINIL
MODAFINIL
At a glance
Nov 01, 2012
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 01, 2012
13 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
MODAFINIL
Strength
100MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 076715
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MODAFINIL
- 1998PROVIGILBrand (NDA)
NDA 020717 · NUVO PHARMS
- 2017MODAFINILGeneric (ANDA)
ANDA 209966 · CADILA
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ANDA 207196 · APPCO
- 2014MODAFINILGeneric (ANDA)
ANDA 077667 · APOTEX
- 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.
