FDA.reportPublic FDA data

Application 062512

Type
ANDA
Sponsor
WOCKHARDT BIO AG

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-4785NystatinNystatinPharmaceutical Associates, Inc.ANDACurrent
17856-0037NystatinNystatinATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0538NystatinNystatinATLANTIC BIOLOGICALS CORP.ANDACurrent
42254-067NystatinNystatinRebel Distributors CorpANDACurrent
50090-1740NystatinnystatinA-S Medication SolutionsANDACurrent
55154-1578NystatinNystatinCardinal Health 107, LLCANDACurrent
55154-1578NystatinNystatinCardinal HealthANDACurrent
55154-1578NystatinNystatinCardinal HealthANDACurrent
55154-1578NystatinNystatinCardinal HealthANDACurrent
60432-537NystatinnystatinMorton Grove Pharmaceuticals, Inc.ANDACurrent
63629-2598NystatinNystatinBryant Ranch PrepackANDACurrent
63739-634NystatinNystatinMcKesson CorporationANDACurrent
63739-634NystatinnystatinMcKesson Corporation dba SKY PackagingANDACurrent
68094-599NystatinNystatinPrecision Dose, Inc.ANDACurrent
68094-599NystatinNystatinPrecision Dose, Inc.ANDACurrent
68094-599NystatinNystatinPrecision Dose, Inc.ANDACurrent
68094-599NystatinNystatinPrecision Dose, Inc.ANDACurrent
68788-6792NystatinNystatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6792NystatinNystatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6792NystatinNystatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6792NystatinNystatinPreferred Pharmaceuticals, Inc.ANDACurrent