FDA.reportPublic FDA data

Application 070173

Type
ANDA
Sponsor
MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DISOPYRAMIDE PHOSPHATEDISOPYRAMIDE PHOSPHATECAPSULE;ORALEQ 100MG BASENoNo
002DISOPYRAMIDE PHOSPHATEDISOPYRAMIDE PHOSPHATECAPSULE;ORALEQ 150MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51407-131DISOPYRAMIDE PHOSPHATEDISOPYRAMIDE PHOSPHATEGolden State Medical Supply Inc.ANDACurrent
51407-132DISOPYRAMIDE PHOSPHATEDISOPYRAMIDE PHOSPHATEGolden State Medical Supply Inc.ANDACurrent
51862-093Disopyramide PhosphateDisopyramide PhosphateMayne Pharma Inc.ANDACurrent
51862-093Disopyramide PhosphateDisopyramide PhosphateMayne Pharma Inc.ANDACurrent
51862-093Disopyramide PhosphateDisopyramide PhosphateMayne Pharma Inc.ANDACurrent
51862-094Disopyramide PhosphateDisopyramide PhosphateMayne Pharma Inc.ANDACurrent
51862-094Disopyramide PhosphateDisopyramide PhosphateMayne Pharma Inc.ANDACurrent
51862-094Disopyramide PhosphateDisopyramide PhosphateMayne Pharma Inc.ANDACurrent
51862-095DISOPYRAMIDE PHOSPHATEDISOPYRAMIDE PHOSPHATEMayne Pharma Inc.ANDACurrent
51862-095DISOPYRAMIDE PHOSPHATEDISOPYRAMIDE PHOSPHATEMayne Pharma Inc.ANDACurrent
51862-096DISOPYRAMIDE PHOSPHATEDISOPYRAMIDE PHOSPHATEMayne Pharma Inc.ANDACurrent
51862-096DISOPYRAMIDE PHOSPHATEDISOPYRAMIDE PHOSPHATEMayne Pharma Inc.ANDACurrent
60429-984Disopyramide PhosphateDisopyramide PhosphateGSMS, IncorporatedANDACurrent
60429-984Disopyramide PhosphateDisopyramide PhosphateGolden State Medical Supply, Inc.ANDACurrent
60429-985Disopyramide PhosphateDisopyramide PhosphateGSMS, IncorporatedANDACurrent
60429-985Disopyramide PhosphateDisopyramide PhosphateGolden State Medical Supply, Inc.ANDACurrent