FDA.reportPublic FDA data

Application 064142

Type
ANDA
Sponsor
VISTAPHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NYSTATINNYSTATINSUSPENSION;ORAL100,000 UNITS/MLNoNo
002NYSTATINNYSTATINSUSPENSION;ORAL100,000 UNITS/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55154-4056NystatinNystatinCardinal Health 107, LLCANDACurrent
55154-4056NystatinNystatinCardinal HealthANDACurrent
55154-4056NystatinNystatinCardinal HealthANDACurrent
55154-4059NystatinNystatinCardinal HealthANDACurrent
55154-4059NystatinNystatinCardinal HealthANDACurrent
55154-4059NystatinNystatinCardinal HealthANDACurrent
66689-008NystatinNystatinVistaPharm, Inc.ANDACurrent
66689-008NystatinNystatinVistaPharm, Inc.ANDACurrent
66689-037NystatinNystatinVistaPharm, Inc.ANDACurrent
66689-037NystatinNystatinVistaPharm, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42783ORIG1998-06-25
18320ORIG1998-06-25
8351ORIG1998-06-25