FDA.reportPublic FDA data

Application 018487

Type
NDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FUROSEMIDEFUROSEMIDETABLET;ORAL20MGNoNo
002FUROSEMIDEFUROSEMIDETABLET;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0208FurosemidefurosemideMylan Pharmaceuticals Inc.NDACurrent
0378-0208FurosemidefurosemideMylan Pharmaceuticals Inc.NDACurrent
0378-0208FurosemidefurosemideMylan Pharmaceuticals Inc.NDACurrent
0378-0208FurosemidefurosemideMylan Pharmaceuticals Inc.NDACurrent
0378-0216FurosemidefurosemideMylan Pharmaceuticals Inc.NDACurrent
0378-0216FurosemidefurosemideMylan Pharmaceuticals Inc.NDACurrent
0378-0216FurosemidefurosemideMylan Pharmaceuticals Inc.NDACurrent
0378-0216FurosemidefurosemideMylan Pharmaceuticals Inc.NDACurrent
43063-806FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-806FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-806FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-806FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.NDACurrent
43353-341FurosemidefurosemideAphena Pharma Solutions - Tennessee, LLCNDACurrent
50090-2323FurosemidefurosemideA-S Medication SolutionsNDACurrent
50090-2560FurosemidefurosemideA-S Medication SolutionsNDACurrent
50090-2560FurosemidefurosemideA-S Medication SolutionsNDACurrent
51079-072FurosemidefurosemideMylan Institutional Inc.NDACurrent
51079-072FurosemidefurosemideMylan Institutional Inc.NDACurrent
51079-072FurosemidefurosemideMylan Institutional Inc.NDACurrent
51079-072FurosemidefurosemideMylan Institutional Inc.NDACurrent
51079-073FurosemidefurosemideMylan Institutional Inc.NDACurrent
51079-073FurosemidefurosemideMylan Institutional Inc.NDACurrent
51079-073FurosemidefurosemideMylan Institutional Inc.NDACurrent
51079-073FurosemidefurosemideMylan Institutional Inc.NDACurrent
53808-0367FurosemideFUROSEMIDEState of Florida DOH Central PharmacyNDACurrent
55154-5539FurosemidefurosemideCardinal HealthNDACurrent
55154-5539FurosemidefurosemideCardinal Health 107, LLCNDACurrent
55154-5539FurosemidefurosemideCardinal HealthNDACurrent
55154-5539FurosemidefurosemideCardinal HealthNDACurrent
55154-5539FurosemidefurosemideCardinal HealthNDACurrent
55154-5540FurosemidefurosemideCardinal HealthNDACurrent
55154-5540FurosemidefurosemideCardinal Health 107, LLCNDACurrent
55154-5540FurosemidefurosemideCardinal HealthNDACurrent
55154-5540FurosemidefurosemideCardinal HealthNDACurrent
55154-5540FurosemidefurosemideCardinal HealthNDACurrent
63629-8057FurosemidefurosemideBryant Ranch PrepackNDACurrent
67046-219FurosemidefurosemideContract Pharmacy Services-PANDACurrent
67296-0691FurosemidefurosemideRedPharm Drug, Inc.NDACurrent
67296-0691FurosemidefurosemideRedPharm Drug, Inc.NDACurrent
68071-2325FurosemidefurosemideNuCare Pharmaceuticals,Inc.NDACurrent
70518-0120FurosemidefurosemideREMEDYREPACK INC.NDACurrent
70518-0580FurosemidefurosemideREMEDYREPACK INC.NDACurrent
70518-0580FurosemidefurosemideREMEDYREPACK INC.NDACurrent
70518-1072FurosemidefurosemideREMEDYREPACK INC.NDACurrent
70518-1072FurosemidefurosemideREMEDYREPACK INC.NDACurrent
70518-1737FurosemidefurosemideREMEDYREPACK INC.NDACurrent
70518-1737FurosemidefurosemideREMEDYREPACK INC.NDACurrent
71335-0397FurosemidefurosemideBryant Ranch PrepackNDACurrent
71335-0397FurosemidefurosemideBryant Ranch PrepackNDACurrent
71335-0601FurosemidefurosemideBryant Ranch PrepackNDACurrent
71335-0601FurosemidefurosemideBryant Ranch PrepackNDACurrent
71335-1632FurosemidefurosemideBryant Ranch PrepackNDACurrent
71610-284FurosemidefurosemideAphena Pharma Solutions - Tennessee, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
11229SUPPL2016-03-14
15019SUPPL2016-03-10
934SUPPL2010-03-03