Orange Book product · Brand (NDA)
CANASA
MESALAMINE
At a glance
Nov 05, 2004
Approved
Brand (NDA)
Application
AB
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 05, 2004
21 yr 11 mo ago
Today
Patent 8217083 expires
Listed drug product patent expiration.
Jun 06, 2028
in 2 yr
Patent 8436051 expires
Listed drug product patent expiration.
Jun 06, 2028
in 2 yr
Pharmaceutical detail
Active ingredient
MESALAMINE
Strength
1GM
Dosage form
SUPPOSITORY
Route
RECTAL
TE code
AB
Application
NDA 021252
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.
- 2013DELZICOLBrand (NDA)
NDA 204412 · ABBVIE
- 2008APRISOBrand (NDA)
NDA 022301 · SALIX
- 2008ASACOL HDBrand (NDA)
NDA 021830 · ABBVIE
- 2007LIALDABrand (NDA)
NDA 022000 · TAKEDA PHARMS USA
- 1993PENTASABrand (NDA)
NDA 020049 · TAKEDA PHARMS USA
- 1992ASACOLBrand (NDA)
NDA 019651 · APIL
- 1990ROWASABrand (NDA)
NDA 019919 · MEDA PHARMS
- 1987ROWASABrand (NDA)
NDA 019618 · MYLAN SPECIALITY LP
- 2026MESALAMINEGeneric (ANDA)
ANDA 220016 · KLM LABS PVT
- 2026MESALAMINEGeneric (ANDA)
ANDA 219997 · DIFGEN PHARMS
- 2025MESALAMINEGeneric (ANDA)
ANDA 219864 · ANNORA PHARMA
- 2025MESALAMINEGeneric (ANDA)
ANDA 215269 · NOVITIUM PHARMA
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8217083 | Jun 06, 2028 | in 2 yr | Product |
| 8436051 | Jun 06, 2028 | in 2 yr | Product |

