Orange Book product · Generic (ANDA)
BALSALAZIDE DISODIUM
BALSALAZIDE DISODIUM
At a glance
Apr 03, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 03, 2025
1 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
BALSALAZIDE DISODIUM
Strength
750MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 219422
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BALSALAZIDE DISODIUM
- 2012GIAZOBrand (NDA)
NDA 022205 · VALEANT PHARMS INTL
- 2000COLAZALBrand (NDA)
NDA 020610 · VALEANT PHARMS INTL
- 2023BALSALAZIDE DISODIUMGeneric (ANDA)
ANDA 217592 · ZYDUS LIFESCIENCES
- 2015BALSALAZIDE DISODIUMGeneric (ANDA)
ANDA 206336 · AARXION ANDA HLDING
- 2007BALSALAZIDE DISODIUMGeneric (ANDA)
ANDA 077883 · APOTEX
- 2007BALSALAZIDE DISODIUMGeneric (ANDA)
ANDA 077806 · HIKMA
- 2007BALSALAZIDE DISODIUMGeneric (ANDA)
ANDA 077807 · NOVITIUM 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.
