Orange Book product · Brand (NDA)
RIZAFILM
RIZATRIPTAN BENZOATE
At a glance
Feb 26, 2026
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 26, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
RIZATRIPTAN BENZOATE
Strength
EQ 5MG BASE
Dosage form
FILM
Route
ORAL
TE code
Not listed
Application
NDA 205394
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 1998MAXALT-MLTBrand (NDA)
NDA 020865 · ORGANON
- 1998MAXALTBrand (NDA)
NDA 020864 · ORGANON LLC
- 2017RIZATRIPTAN BENZOATEGeneric (ANDA)
ANDA 207835 · UNICHEM
- 2017RIZATRIPTAN BENZOATEGeneric (ANDA)
ANDA 207836 · UNICHEM
- 2017RIZATRIPTAN BENZOATEGeneric (ANDA)
ANDA 204722 · PANACEA
- 2016RIZATRIPTAN BENZOATEGeneric (ANDA)
ANDA 203269 · ALKEM LABS LTD
- 2015RIZATRIPTAN BENZOATEGeneric (ANDA)
ANDA 203334 · JUBILANT GENERICS
- 2014RIZATRIPTAN BENZOATEGeneric (ANDA)
ANDA 203252 · JUBILANT GENERICS
- 2014RIZATRIPTAN BENZOATEGeneric (ANDA)
ANDA 203146 · MACLEODS PHARMS LTD
- 2014RIZATRIPTAN BENZOATEGeneric (ANDA)
ANDA 203147 · MACLEODS PHARMS LTD
- 2013RIZATRIPTAN BENZOATEGeneric (ANDA)
ANDA 204090 · AVET LIFESCIENCES
- 2013RIZATRIPTAN BENZOATEGeneric (ANDA)
ANDA 202477 · APOTEX 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.
