FDA.reportPublic FDA data

Application 050742

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STROMECTOLIVERMECTINTABLET;ORAL6MGNoNo
002STROMECTOLIVERMECTINTABLET;ORAL3MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-0032STROMECTOLivermectinMerck Sharp & Dohme Corp.NDACurrent
0006-0032STROMECTOLivermectinMerck Sharp & Dohme Corp.NDACurrent
0006-0032STROMECTOLivermectinMerck Sharp & Dohme Corp.NDACurrent
0006-0032STROMECTOLivermectinMerck Sharp & Dohme LLCNDACurrent
0006-0032STROMECTOLivermectinMerck Sharp & Dohme Corp.NDACurrent
0006-0032STROMECTOLivermectinMerck Sharp & Dohme Corp.NDACurrent
55695-019STROMECTOLivermectinDepartment of State Health Services, Pharmacy BranchNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70532SUPPL2022-03-16
70526SUPPL2022-03-16
30427SUPPL2009-12-24
39234SUPPL2009-12-16
39233SUPPL2009-06-22
18159SUPPL2009-06-22
8163SUPPL2009-06-17
8162SUPPL2009-06-17
39232SUPPL2009-05-11
30426SUPPL2008-09-16
18158SUPPL2008-09-16
8160SUPPL2008-02-27
30425SUPPL2007-10-04
8161SUPPL2007-10-04
39231SUPPL2007-09-26
18157SUPPL2007-09-26
30424SUPPL2006-01-30
8159SUPPL2006-01-30
39230SUPPL2006-01-27
18156SUPPL2006-01-27
42713SUPPL2005-03-08
18155SUPPL2004-12-02
39229SUPPL2004-03-03
18154SUPPL2004-03-03
30423SUPPL2004-02-27
8158SUPPL2004-02-27
39228SUPPL2003-01-15
30422SUPPL2003-01-15
22213ORIG1997-11-26