FDA.reportPublic FDA data

Application 020762

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NASONEXMOMETASONE FUROATESPRAY, METERED;NASAL0.05MG/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-1288NASONEXMometasone furoate monohydrateMerck Sharp & Dohme Corp.NDACurrent
0085-1288NASONEXMometasone furoate monohydrateMerck Sharp & Dohme Corp.NDACurrent
0085-1288NASONEXMometasone furoate monohydrateMerck Sharp & Dohme Corp.NDACurrent
0085-1288NASONEXMometasone furoate monohydrateMerck Sharp & Dohme Corp.NDACurrent
0781-6355Mometasone Furoate MonohydrateMometasone Furoate MonohydrateSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-6355Mometasone Furoate MonohydrateMometasone Furoate MonohydrateSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-6355Mometasone Furoate MonohydrateMometasone Furoate MonohydrateSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-6355Mometasone Furoate MonohydrateMometasone Furoate MonohydrateSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-6355Mometasone Furoate MonohydrateMometasone Furoate MonohydrateSandoz Inc.NDA AUTHORIZED GENERICCurrent
50090-0620NASONEXMometasone furoate monohydrateA-S Medication SolutionsNDACurrent
78206-144NASONEXMometasone furoate monohydrateOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71479SUPPL2022-06-29
71476SUPPL2022-06-29
64553SUPPL2020-09-11
64543SUPPL2020-09-10
54790SUPPL2018-07-06
54715SUPPL2018-06-28
54714SUPPL2018-06-28
54708SUPPL2018-06-27
54707SUPPL2018-06-27
41675SUPPL2016-07-27
20919SUPPL2016-07-27
20918SUPPL2016-07-27
41674SUPPL2013-02-27
25726SUPPL2011-01-25
13360SUPPL2011-01-25
3282SUPPL2010-06-02
35289SUPPL2010-05-28
41670ORIG2010-03-03
41672SUPPL2008-04-02
41673SUPPL2007-07-09
25725SUPPL2004-12-30
13359SUPPL2004-12-30
13356SUPPL2004-08-31
3280SUPPL2004-08-31
13358SUPPL2003-12-29
25724SUPPL2003-12-23
3281SUPPL2003-03-10
25723SUPPL2002-07-17
13357SUPPL2002-07-17
41671SUPPL1998-11-18
25722SUPPL1998-11-18
53343ORIG1900-01-01
53342ORIG1900-01-01
53341ORIG1900-01-01
53340ORIG1900-01-01
53339ORIG1900-01-01