Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077645
Company: AUROBINDO PHARMA LTD

• Healthcare Professional Sheet

Products on ANDA 077645

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE;ORAL	Prescription	AB	No	No
ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE;ORAL	Prescription	AB	No	No
ZONISAMIDE	ZONISAMIDE	50MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077645

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2005	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077645ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/08/2023	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/08/2023	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/30/2012	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/29/2010	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
02/26/2010	SUPPL-2	Labeling-Package Insert, REMS-Proposal		Label is not available on this site.

Therapeutic Equivalents for ANDA 077645

ZONISAMIDE

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

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