Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077651
Company: GLENMARK PHARMS

• Healthcare Professional Sheet

Products on ANDA 077651

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 077651

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/30/2006	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
05/25/2022	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
07/18/2016	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
10/26/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
06/13/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
05/30/2012	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
02/26/2010	SUPPL-8	REMS-Proposal, Labeling-Package Insert		Label is not available on this site.
09/12/2007	SUPPL-2	Labeling		Label is not available on this site.
05/01/2006	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077651

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	ADVANZ PHARMA
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
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	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	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
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	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	ADVANZ PHARMA
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
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	214492	UNICHEM
ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE;ORAL	Prescription	No	AB	077625	ZYDUS LIFESCIENCES