FDA.report

Application 077634

Type
ANDA
Sponsor
SUN PHARM INDS (IN)

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ZONISAMIDEZONISAMIDECAPSULE;ORAL25MGNoNo
002ZONISAMIDEZONISAMIDECAPSULE;ORAL50MGNoNo
003ZONISAMIDEZONISAMIDECAPSULE;ORAL100MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-155ZONISAMIDEZONISAMIDERebel Distributors CorpANDACurrent
21695-654ZONISAMIDEZONISAMIDERebel Distributors CorpANDACurrent
35356-143ZONISAMIDEZONISAMIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-143ZONISAMIDEZONISAMIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-143ZONISAMIDEZONISAMIDEQuality Care Products LLCANDACurrent
35356-143ZONISAMIDEZONISAMIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
43063-932ZonisamideZonisamidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-932ZonisamideZonisamidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-932ZonisamideZonisamidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-932ZonisamideZonisamidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-932ZonisamideZonisamidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-932ZonisamideZonisamidePD-Rx Pharmaceuticals, Inc.ANDACurrent
51407-137ZonisamideZonisamideGolden State Medical Supply, Inc.ANDACurrent
51407-137ZonisamideZonisamideGolden State Medical Supply, Inc.ANDACurrent
51407-137ZonisamideZonisamideGolden State Medical Supply, Inc.ANDACurrent
51407-137ZonisamideZonisamideGolden State Medical Supply, Inc.ANDACurrent
51407-137ZonisamideZonisamideGolden State Medical Supply IncANDACurrent
51407-138ZonisamideZonisamideGolden State Medical Supply IncANDACurrent
51407-138ZonisamideZonisamideGolden State Medical Supply, Inc.ANDACurrent
51407-138ZonisamideZonisamideGolden State Medical Supply, Inc.ANDACurrent
51407-138ZonisamideZonisamideGolden State Medical Supply, Inc.ANDACurrent
51407-138ZonisamideZonisamideGolden State Medical Supply, Inc.ANDACurrent
51407-139ZonisamideZonisamideGolden State Medical Supply IncANDACurrent
51407-139ZonisamideZonisamideGolden State Medical Supply, Inc.ANDACurrent
51407-139ZonisamideZonisamideGolden State Medical Supply, Inc.ANDACurrent
51407-139ZonisamideZonisamideGolden State Medical Supply, Inc.ANDACurrent
51407-139ZonisamideZonisamideGolden State Medical Supply, Inc.ANDACurrent
61919-275ZONISAMIDEZONISAMIDEDirectRXANDACurrent
61919-917ZONISAMIDEZONISAMIDEDirect_RxANDACurrent
61919-917ZONISAMIDEZONISAMIDEDirect_RxANDACurrent
61919-917ZONISAMIDEZONISAMIDEDirect_RxANDACurrent
61919-917ZONISAMIDEZONISAMIDEDIRECT RXANDACurrent
61919-917ZONISAMIDEZONISAMIDEDirect_RxANDACurrent
62756-258ZonisamideZonisamideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-258ZonisamideZonisamideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-259ZonisamideZonisamideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-259ZonisamideZonisamideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-260ZonisamideZonisamideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-260ZonisamideZonisamideSun Pharmaceutical Industries, Inc.ANDACurrent
63187-897ZonisamideZonisamideProficient Rx LPANDACurrent
63187-897ZonisamideZonisamideProficient Rx LPANDACurrent
63187-897ZonisamideZonisamideProficient Rx LPANDACurrent
63187-897ZonisamideZonisamideProficient Rx LPANDACurrent
63629-3293ZONISAMIDEZONISAMIDEBryant Ranch PrepackANDACurrent
63629-3293ZonisamideZonisamideBryant Ranch PrepackANDACurrent
63629-4565ZONISAMIDEZONISAMIDEBryant Ranch PrepackANDACurrent
68788-7438ZonisamideZonisamidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7438ZonisamideZonisamidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7438ZonisamideZonisamidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7438ZonisamideZonisamidePreferred Pharmaceuticals, Inc.ANDACurrent
70518-1701ZonisamideZonisamideREMEDYREPACK INC.ANDACurrent
70518-1701ZonisamideZonisamideREMEDYREPACK INC.ANDACurrent
70518-1701ZonisamideZonisamideREMEDYREPACK INC.ANDACurrent
70518-1701ZonisamideZonisamideREMEDYREPACK INC.ANDACurrent
71335-0962ZonisamideZonisamideBryant Ranch PrepackANDACurrent
71335-0962ZonisamideZonisamideBryant Ranch PrepackANDACurrent
71335-0962ZonisamideZonisamideBryant Ranch PrepackANDACurrent
72189-374ZonisamideZonisamideDirect_RxANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.Date
241590ORIG12008-02-01