Orange Book product · Brand (NDA)
ZONEGRAN
ZONISAMIDE
At a glance
Aug 22, 2003
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 22, 2003
23 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ZONISAMIDE
Strength
25MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 020789
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2022ZONISADEBrand (NDA)
NDA 214273 · AZURITY
- 2025ZONISAMIDEGeneric (ANDA)
ANDA 219507 · MACLEODS PHARMS LTD
- 2021ZONISAMIDEGeneric (ANDA)
ANDA 214492 · UNICHEM
- 2007ZONISAMIDEGeneric (ANDA)
ANDA 077876 · EPIC PHARMA LLC
- 2006ZONISAMIDEGeneric (ANDA)
ANDA 077625 · ZYDUS LIFESCIENCES
- 2006ZONISAMIDEGeneric (ANDA)
ANDA 077645 · AUROBINDO PHARMA LTD
- 2006ZONISAMIDEGeneric (ANDA)
ANDA 077813 · BIONPHARMA
- 2006ZONISAMIDEGeneric (ANDA)
ANDA 077636 · GRANULES
- 2006ZONISAMIDEGeneric (ANDA)
ANDA 077869 · INVAGEN PHARMS
- 2006ZONISAMIDEGeneric (ANDA)
ANDA 077650 · CHARTWELL RX
- 2006ZONISAMIDEGeneric (ANDA)
ANDA 077634 · SUN PHARM INDS (IN)
- 2006ZONISAMIDEGeneric (ANDA)
ANDA 077651 · GLENMARK PHARMS
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.
