FDA.reportPublic FDA data

Application 019389

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BECONASE AQBECLOMETHASONE DIPROPIONATE MONOHYDRATESPRAY, METERED;NASALEQ 0.042MG DIPROP/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0388BECONASEbeclomethasone dipropionate monohydrateGlaxoSmithKline LLCNDACurrent
0173-0388BECONASEbeclomethasone dipropionate monohydrateGlaxoSmithKline LLCNDACurrent
0173-0388BECONASEbeclomethasone dipropionate monohydrateGlaxoSmithKline LLCNDACurrent
0173-0388BECONASEbeclomethasone dipropionate monohydrateGlaxoSmithKline LLCNDACurrent
0173-0388BECONASEbeclomethasone dipropionate monohydrateGlaxoSmithKline LLCNDACurrent
0173-0388BECONASEbeclomethasone dipropionate monohydrateGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58349SUPPL2019-04-18
58329SUPPL2019-04-15
33736SUPPL2005-11-01
1313SUPPL2005-11-01
33735SUPPL2003-04-15
17384SUPPL2002-12-19
17385SUPPL2002-12-16