FDA.reportPublic FDA data

Application 075442

Type
ANDA
Sponsor
AMNEAL PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLECAINIDE ACETATEFLECAINIDE ACETATETABLET;ORAL50MGNoNo
002FLECAINIDE ACETATEFLECAINIDE ACETATETABLET;ORAL100MGNoNo
003FLECAINIDE ACETATEFLECAINIDE ACETATETABLET;ORAL150MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-293Flecainide AcetateFlecainide AcetateAvKARE, Inc.ANDACurrent
42291-293Flecainide AcetateFlecainide AcetateAvKARE, Inc.ANDACurrent
42291-293Flecainide AcetateFlecainide AcetateAvKARE, Inc.ANDACurrent
42291-294Flecainide AcetateFlecainide AcetateAvKARE, Inc.ANDACurrent
42291-294Flecainide AcetateFlecainide AcetateAvKARE, Inc.ANDACurrent
42291-294Flecainide AcetateFlecainide AcetateAvKARE, Inc.ANDACurrent
42291-295Flecainide AcetateFlecainide AcetateAvKARE, Inc.ANDACurrent
42291-295Flecainide AcetateFlecainide AcetateAvKARE, Inc.ANDACurrent
50090-1133Flecainide AcetateFlecainide AcetateA-S Medication SolutionsANDACurrent
50268-320Flecainide AcetateFlecainide AcetateAvPAKANDACurrent
50268-320Flecainide AcetateFlecainide AcetateAvPAKANDACurrent
50268-320Flecainide AcetateFlecainide AcetateAvPAKANDACurrent
50268-321Flecainide AcetateFlecainide AcetateAvPAKANDACurrent
50268-321Flecainide AcetateFlecainide AcetateAvPAKANDACurrent
50268-321Flecainide AcetateFlecainide AcetateAvPAKANDACurrent
50268-322Flecainide AcetateFlecainide AcetateAvPAKANDACurrent
53746-641Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals of New York LLCANDACurrent
53746-641Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals of New York LLCANDACurrent
53746-641Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals of New York LLCANDACurrent
53746-641Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals of New York LLCANDACurrent
53746-641Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals of New York LLCANDACurrent
53746-642Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals of New York LLCANDACurrent
53746-642Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals of New York LLCANDACurrent
53746-642Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals of New York LLCANDACurrent
53746-642Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals of New York LLCANDACurrent
53746-642Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals of New York LLCANDACurrent
53746-643Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals of New York LLCANDACurrent
53746-643Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals of New York LLCANDACurrent
53746-643Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals of New York LLCANDACurrent
53746-643Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals of New York LLCANDACurrent
53746-643Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals of New York LLCANDACurrent
60687-225Flecainide AcetateFlecainide AcetateAmerican Health PackagingANDACurrent
65162-641Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals LLCANDACurrent
65162-641Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals LLCANDACurrent
65162-641Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals LLCANDACurrent
65162-641Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals LLCANDACurrent
65162-642Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals LLCANDACurrent
65162-642Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals LLCANDACurrent
65162-642Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals LLCANDACurrent
65162-642Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals LLCANDACurrent
65162-643Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals LLCANDACurrent
65162-643Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals LLCANDACurrent
65162-643Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals LLCANDACurrent
65162-643Flecainide AcetateFlecainide AcetateAmneal Pharmaceuticals LLCANDACurrent
68084-540Flecainide AcetateFlecainide AcetateAmerican Health PackagingANDACurrent