FDA.reportPublic FDA data

Application 087946

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOSORBIDE DINITRATEISOSORBIDE DINITRATETABLET;ORAL30MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7584Isosorbide Dinitrateisosorbide dinitrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8193Isosorbide Dinitrateisosorbide dinitrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8193Isosorbide Dinitrateisosorbide dinitrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42291-350Isosorbide Dinitrateisosorbide dinitrateAvKARE, Inc.ANDACurrent
42291-350Isosorbide Dinitrateisosorbide dinitrateAvKAREANDACurrent
49884-009Isosorbide Dinitrateisosorbide dinitratePar Pharmaceutical, Inc.ANDACurrent
49884-009Isosorbide Dinitrateisosorbide dinitratePar Pharmaceutical, Inc.ANDACurrent
49884-009Isosorbide Dinitrateisosorbide dinitratePar Pharmaceutical, Inc.ANDACurrent
49884-009Isosorbide Dinitrateisosorbide dinitratePar Pharmaceutical, Inc.ANDACurrent
49884-009Isosorbide Dinitrateisosorbide dinitratePar Pharmaceutical, Inc.ANDACurrent
68151-1980Isosorbide Dinitrateisosorbide dinitrateCarilion Materials ManagementANDACurrent
68151-2476Isosorbide Dinitrateisosorbide dinitrateCarilion Materials ManagementANDACurrent
70518-2306Isosorbide Dinitrateisosorbide dinitrateREMEDYREPACK INC.ANDACurrent
70518-2306Isosorbide Dinitrateisosorbide dinitrateREMEDYREPACK INC.ANDACurrent
70518-2306Isosorbide Dinitrateisosorbide dinitrateREMEDYREPACK INC.ANDACurrent
70518-2306Isosorbide Dinitrateisosorbide dinitrateREMEDYREPACK INC.ANDACurrent