Orange Book product · Generic (ANDA)
MESALAMINE
MESALAMINE
At a glance
May 30, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 30, 2023
3 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
MESALAMINE
Strength
4GM/60ML
Dosage form
ENEMA
Route
RECTAL
TE code
AB
Application
ANDA 216941
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MESALAMINE
- 2013DELZICOLBrand (NDA)
NDA 204412 · ABBVIE
- 2008APRISOBrand (NDA)
NDA 022301 · SALIX
- 2008ASACOL HDBrand (NDA)
NDA 021830 · ABBVIE
- 2007LIALDABrand (NDA)
NDA 022000 · TAKEDA PHARMS USA
- 2004CANASABrand (NDA)
NDA 021252 · ABBVIE
- 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
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.
