Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077625
Company: ZYDUS PHARMS USA
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
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
05/30/2012 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-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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 SUNOVION PHARMS INC
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077642 APOTEX INC
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077813 BIONPHARMA INC
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077651 GLENMARK GENERICS
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077869 INVAGEN PHARMS
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077637 MYLAN
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077634 SUN PHARM INDS (IN)
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077636 WOCKHARDT
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077625 ZYDUS PHARMS USA

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 077813 BIONPHARMA INC
ZONISAMIDE ZONISAMIDE 50MG CAPSULE;ORAL Prescription No AB 077651 GLENMARK GENERICS
ZONISAMIDE ZONISAMIDE 50MG CAPSULE;ORAL Prescription No AB 077869 INVAGEN PHARMS
ZONISAMIDE ZONISAMIDE 50MG CAPSULE;ORAL Prescription No AB 077637 MYLAN
ZONISAMIDE ZONISAMIDE 50MG CAPSULE;ORAL Prescription No AB 077634 SUN PHARM INDS (IN)
ZONISAMIDE ZONISAMIDE 50MG CAPSULE;ORAL Prescription No AB 077636 WOCKHARDT
ZONISAMIDE ZONISAMIDE 50MG CAPSULE;ORAL Prescription No AB 077625 ZYDUS PHARMS USA

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 SUNOVION PHARMS INC
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077642 APOTEX INC
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077813 BIONPHARMA INC
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077651 GLENMARK GENERICS
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077869 INVAGEN PHARMS
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077637 MYLAN
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077634 SUN PHARM INDS (IN)
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077636 WOCKHARDT
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077625 ZYDUS PHARMS USA

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