FDA.reportPublic FDA data

Application 019591

Type
NDA
Sponsor
ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LARIAMMEFLOQUINE HYDROCHLORIDETABLET;ORAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72422SUPPL2022-10-19
72421SUPPL2022-10-19
72420SUPPL2022-10-19
72419SUPPL2022-10-19
72418SUPPL2022-10-19
72417SUPPL2022-10-19
72416SUPPL2022-10-19
72413SUPPL2022-10-19
72412SUPPL2022-10-19
72313SUPPL2022-10-12
56374SUPPL2018-11-08
17472SUPPL2011-05-04
17471SUPPL2009-11-19
17469SUPPL2009-11-19
43622ORIG2009-09-25
11549SUPPL2009-09-17
11547SUPPL2009-09-17
11548SUPPL2009-07-24
17470SUPPL2009-06-30
33808SUPPL2008-10-03
33807SUPPL2008-10-03
17468SUPPL2008-09-26
1402SUPPL2008-09-26
11546SUPPL2008-06-05
17467SUPPL2008-05-14
11545SUPPL2003-09-08
11544SUPPL2003-09-08
1401SUPPL2003-09-08
17466SUPPL2003-07-10
33806SUPPL2003-07-09
33805SUPPL2003-01-10
33804SUPPL2003-01-10
17465SUPPL2003-01-10
1400SUPPL2003-01-10
11543ORIG2002-10-04