FDA.reportPublic FDA data

Application 020763

Type
NDA
Sponsor
GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMERGENARATRIPTAN HYDROCHLORIDETABLET;ORALEQ 2.5MG BASEYesYes
002AMERGENARATRIPTAN HYDROCHLORIDETABLET;ORALEQ 1MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0561AMERGEnaratriptan hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0561AMERGEnaratriptan hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0561AMERGEnaratriptan hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0561AMERGEnaratriptan hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0562AMERGEnaratriptan hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0562AMERGEnaratriptan hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0562AMERGEnaratriptan hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0562AMERGEnaratriptan hydrochlorideGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45995SUPPL2016-12-01
45972SUPPL2016-12-01
35295SUPPL2013-10-18
35292SUPPL2013-10-18
35291SUPPL2013-10-18
25732SUPPL2013-10-18
25728SUPPL2013-10-18
3283SUPPL2013-10-18
35294SUPPL2012-03-06
13361SUPPL2012-03-06
25731SUPPL2012-03-05
3284SUPPL2012-03-05
35293SUPPL2010-08-19
25730SUPPL2010-08-16
20920ORIG2004-05-27
23597ORIG2003-12-08
25729SUPPL2003-11-05
35290ORIG1998-02-10
25727ORIG1998-02-10