Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 214492
Company: UNICHEM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription AB No No
ZONISAMIDE ZONISAMIDE 50MG CAPSULE;ORAL Prescription AB No No
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/26/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

ZONISAMIDE

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZONEGRAN ZONISAMIDE 25MG CAPSULE;ORAL Prescription Yes AB 020789 CONCORDIA
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077642 APOTEX INC
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077645 AUROBINDO PHARMA LTD
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077813 BIONPHARMA INC
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077625 CADILA
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077651 GLENMARK GENERICS
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077636 GRANULES
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077869 INVAGEN PHARMS
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077634 SUN PHARM INDS (IN)
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 214492 UNICHEM

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZONISAMIDE ZONISAMIDE 50MG CAPSULE;ORAL Prescription No AB 077642 APOTEX INC
ZONISAMIDE ZONISAMIDE 50MG CAPSULE;ORAL Prescription No AB 077645 AUROBINDO PHARMA LTD
ZONISAMIDE ZONISAMIDE 50MG CAPSULE;ORAL Prescription No AB 077813 BIONPHARMA INC
ZONISAMIDE ZONISAMIDE 50MG CAPSULE;ORAL Prescription No AB 077625 CADILA
ZONISAMIDE ZONISAMIDE 50MG CAPSULE;ORAL Prescription No AB 077651 GLENMARK GENERICS
ZONISAMIDE ZONISAMIDE 50MG CAPSULE;ORAL Prescription No AB 077636 GRANULES
ZONISAMIDE ZONISAMIDE 50MG CAPSULE;ORAL Prescription No AB 077869 INVAGEN PHARMS
ZONISAMIDE ZONISAMIDE 50MG CAPSULE;ORAL Prescription No AB 077634 SUN PHARM INDS (IN)
ZONISAMIDE ZONISAMIDE 50MG CAPSULE;ORAL Prescription No AB 214492 UNICHEM

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZONEGRAN ZONISAMIDE 100MG CAPSULE;ORAL Prescription Yes AB 020789 CONCORDIA
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077642 APOTEX INC
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077645 AUROBINDO PHARMA LTD
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077813 BIONPHARMA INC
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077625 CADILA
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077651 GLENMARK GENERICS
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077636 GRANULES
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077869 INVAGEN PHARMS
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077634 SUN PHARM INDS (IN)
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 214492 UNICHEM

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English