Orange Book product · Generic (ANDA)
BALSALAZIDE DISODIUM
BALSALAZIDE DISODIUM
At a glance
Sep 08, 2015
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 08, 2015
10 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
BALSALAZIDE DISODIUM
Strength
1.1GM
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 206336
Product number
001
Marketing status
DISCN
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
- 2025BALSALAZIDE DISODIUMGeneric (ANDA)
ANDA 219422 · CARNEGIE
- 2023BALSALAZIDE DISODIUMGeneric (ANDA)
ANDA 217592 · ZYDUS LIFESCIENCES
- 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.
