FDA.reportPublic FDA data

Application 077869

Type
ANDA
Sponsor
INVAGEN PHARMS

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
0615-8266zonisamidezonisamideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8266zonisamidezonisamideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8266zonisamidezonisamideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
31722-228ZonisamideZonisamideCamber PharmaceuticalsANDACurrent
50268-816ZonisamideZonisamideAvPAKANDACurrent
50268-816ZonisamideZonisamideAvPAKANDACurrent
50268-816ZonisamideZonisamideAvPAKANDACurrent
53217-301zonisamidezonisamideAidarex Pharmaceuticals LLCANDACurrent
60687-230ZonisamideZonisamideAmerican Health PackagingANDACurrent
60687-230ZonisamideZonisamideAmerican Health PackagingANDACurrent
60687-230ZonisamideZonisamideAmerican Health PackagingANDACurrent
60687-230ZonisamideZonisamideAmerican Health PackagingANDACurrent
69097-861zonisamidezonisamideCipla USA Inc.ANDACurrent
69097-861zonisamidezonisamideCipla USA Inc.ANDACurrent
70518-3180zonisamidezonisamideREMEDYREPACK INC.ANDACurrent
71335-0486zonisamidezonisamideBryant Ranch PrepackANDACurrent
71335-0486zonisamidezonisamideBryant Ranch PrepackANDACurrent
71335-0486zonisamidezonisamideBryant Ranch PrepackANDACurrent
76282-226ZonisamideZonisamideExelan Pharmaceuticals, Inc.ANDACurrent
76282-226ZonisamideZonisamideExelan Pharmaceuticals, Inc.ANDACurrent
76282-226ZonisamideZonisamideExelan Pharmaceuticals, Inc.ANDACurrent
76282-227ZonisamideZonisamideExelan Pharmaceuticals, Inc.ANDACurrent
76282-227ZonisamideZonisamideExelan Pharmaceuticals, Inc.ANDACurrent
76282-227ZonisamideZonisamideExelan Pharmaceuticals, Inc.ANDACurrent
76282-228ZonisamideZonisamideExelan Pharmaceuticals, Inc.ANDACurrent
76282-228ZonisamideZonisamideExelan Pharmaceuticals, Inc.ANDACurrent
76282-228ZonisamideZonisamideExelan Pharmaceuticals, Inc.ANDACurrent
76282-228ZonisamideZonisamideExelan Pharmaceuticals, Inc.ANDACurrent
76282-228ZonisamideZonisamideExelan Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44628ORIG2008-02-01