Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077813
Company: BIONPHARMA

• Healthcare Professional Sheet

Products on ANDA 077813

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077813

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/16/2006	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/01/2022	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/25/2019	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077813

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
ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE;ORAL	Prescription	No	AB	077651	GLENMARK PHARMS INC
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
ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE;ORAL	Prescription	No	AB	077625	ZYDUS LIFESCIENCES

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
ZONISAMIDE	ZONISAMIDE	50MG	CAPSULE;ORAL	Prescription	No	AB	077651	GLENMARK PHARMS INC
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
ZONISAMIDE	ZONISAMIDE	50MG	CAPSULE;ORAL	Prescription	No	AB	077625	ZYDUS LIFESCIENCES

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
ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE;ORAL	Prescription	No	AB	077651	GLENMARK PHARMS INC
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
ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE;ORAL	Prescription	No	AB	077625	ZYDUS LIFESCIENCES