Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077645
Company: AUROBINDO PHARMA LTD
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
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
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 REMS-Proposal, Labeling-Package Insert

Label is not available on this site.

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 INC
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; 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 INC
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

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 INC
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

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