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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077636
Company: GRANULES

Healthcare Professional Sheet

Products on ANDA 077636

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	50MG	CAPSULE;ORAL	Prescription	AB	No	No
ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077636

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/2005/077636rev2.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/08/2023	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
03/08/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/13/2010	SUPPL-3	REMS-Proposal		Label is not available on this site.
07/27/2006	SUPPL-2	Labeling		Label is not available on this site.
07/27/2006	SUPPL-1	Manufacturing (CMC)-New Strength		Label is not available on this site.

Therapeutic Equivalents for ANDA 077636

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	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	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

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	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; 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	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

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