FDA.reportPublic FDA data

Application 074246

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIMETIDINECIMETIDINETABLET;ORAL200MGNoNo
002CIMETIDINECIMETIDINETABLET;ORAL300MGNoNo
003CIMETIDINECIMETIDINETABLET;ORAL400MGNoNo
004CIMETIDINECIMETIDINETABLET;ORAL800MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0053CimetidinecimetidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0053CimetidinecimetidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0053CimetidinecimetidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0053CimetidinecimetidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0317CimetidinecimetidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0317CimetidinecimetidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0317CimetidinecimetidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0317CimetidinecimetidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0372CimetidinecimetidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0372CimetidinecimetidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0372CimetidinecimetidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0372CimetidinecimetidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0541CimetidinecimetidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0541CimetidinecimetidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0541CimetidinecimetidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0541CimetidinecimetidineMylan Pharmaceuticals Inc.ANDACurrent
50090-3574CimetidinecimetidineA-S Medication SolutionsANDACurrent
50090-3574CimetidinecimetidineA-S Medication SolutionsANDACurrent
55289-581CimetidinecimetidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-581CimetidinecimetidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-581CimetidinecimetidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-581CimetidinecimetidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-581CimetidinecimetidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
68151-1497CimetidinecimetidineCarilion Materials ManagementANDACurrent
70518-2809CimetidinecimetidineREMEDYREPACK INC.ANDACurrent
70518-2809CimetidinecimetidineREMEDYREPACK INC.ANDACurrent