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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019389-001BECONASE AQBECLOMETHASONE DIPROPIONATE MONOHYDRATEEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-27a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

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