FDA.reportPublic FDA data

Application 077637

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZONISAMIDEZONISAMIDECAPSULE;ORAL25MGNoNo
002ZONISAMIDEZONISAMIDECAPSULE;ORAL50MGNoNo
003ZONISAMIDEZONISAMIDECAPSULE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6725ZonisamidezonisamideMylan Pharmaceuticals Inc.ANDACurrent
0378-6725ZonisamidezonisamideMylan Pharmaceuticals IncANDACurrent
0378-6726ZonisamidezonisamideMylan Pharmaceuticals Inc.ANDACurrent
0378-6726ZonisamidezonisamideMylan Pharmaceuticals IncANDACurrent
0378-6727ZonisamidezonisamideMylan Pharmaceuticals Inc.ANDACurrent
0378-6727ZonisamidezonisamideMylan Pharmaceuticals IncANDACurrent
0615-1379ZonisamidezonisamideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43063-575ZonisamidezonisamidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-575ZonisamidezonisamidePD-Rx Pharmaceuticals, Inc.ANDACurrent
51079-768ZonisamidezonisamideMylan Institutional Inc.ANDACurrent
55700-204ZonisamidezonisamideLake Erie Medical DBA Quality Care Products LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44622ORIG2008-02-01
9069ORIG2005-12-28