An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077625
Company: ZYDUS LIFESCIENCES

Healthcare Professional Sheet

Products on ANDA 077625

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 077625

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2006	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
05/25/2022	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/12/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
05/30/2012	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
05/30/2012	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/27/2011	SUPPL-4	REMS-Modified		Label is not available on this site.
08/11/2010	SUPPL-3	REMS-Proposal		Label is not available on this site.
08/11/2010	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 077625

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

Top