FDA.reportPublic FDA data

Application 072489

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETYLCYSTEINEACETYLCYSTEINESOLUTION;INHALATION, ORAL10%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-7504AcetylcysteineacetylcysteineAmerican Regent, Inc.ANDACurrent
0517-7504AcetylcysteineacetylcysteineAmerican Regent, Inc.ANDACurrent
0517-7504AcetylcysteineacetylcysteineAmerican Regent, Inc.ANDACurrent
0517-7510AcetylcysteineacetylcysteineAmerican Regent, Inc.ANDACurrent
0517-7510AcetylcysteineacetylcysteineAmerican Regent, Inc.ANDACurrent
0517-7510AcetylcysteineacetylcysteineAmerican Regent, Inc.ANDACurrent
55154-5730AcetylcysteineAcetylcysteineCardinal Health 107, LLCANDACurrent
55154-5730AcetylcysteineAcetylcysteineCardinal HealthANDACurrent
55154-5730AcetylcysteineAcetylcysteineCardinal HealthANDACurrent
55154-5730AcetylcysteineAcetylcysteineCardinal HealthANDACurrent