FDA.reportPublic FDA data

Application 091656

Type
ANDA
Sponsor
CADILA PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OFLOXACINOFLOXACINTABLET;ORAL200MGNoNo
002OFLOXACINOFLOXACINTABLET;ORAL300MGNoNo
003OFLOXACINOFLOXACINTABLET;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71209-097OFLOXACINOFLOXACINCadila Pharmaceuticals LimitedANDACurrent
71209-097OFLOXACINOFLOXACINCadila Pharmaceuticals LimitedANDACurrent
71209-097OFLOXACINOFLOXACINCadila Pharmaceuticals LimitedANDACurrent
71209-097OFLOXACINOFLOXACINCadila Pharmaceuticals LimitedANDACurrent
71209-098OFLOXACINOFLOXACINCadila Pharmaceuticals LimitedANDACurrent
71209-098OFLOXACINOFLOXACINCadila Pharmaceuticals LimitedANDACurrent
71209-098OFLOXACINOFLOXACINCadila Pharmaceuticals LimitedANDACurrent
71209-098OFLOXACINOFLOXACINCadila Pharmaceuticals LimitedANDACurrent
71209-099OFLOXACINOFLOXACINCadila Pharmaceuticals LimitedANDACurrent
71209-099OFLOXACINOFLOXACINCadila Pharmaceuticals LimitedANDACurrent
71209-099OFLOXACINOFLOXACINCadila Pharmaceuticals LimitedANDACurrent
71209-099OFLOXACINOFLOXACINCadila Pharmaceuticals LimitedANDACurrent
75834-112OFLOXACINOFLOXACINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-112OFLOXACINOFLOXACINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-112OFLOXACINOFLOXACINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-119OFLOXACINOFLOXACINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-119OFLOXACINOFLOXACINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-119OFLOXACINOFLOXACINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-120OFLOXACINOFLOXACINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-120OFLOXACINOFLOXACINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-120OFLOXACINOFLOXACINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-199OFLOXACINOFLOXACINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-200OFLOXACINOFLOXACINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-201OFLOXACINOFLOXACINNivagen Pharmaceuticals, Inc.ANDACurrent