FDA.reportPublic FDA data

Application 020788

Type
NDA
Sponsor
MERCK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPECIAFINASTERIDETABLET;ORAL1MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-0071PROPECIAfinasterideMerck Sharp & Dohme Corp.NDACurrent
0006-0071PROPECIAfinasterideMerck Sharp & Dohme Corp.NDACurrent
0006-0071PROPECIAfinasterideMerck Sharp & Dohme Corp.NDACurrent
0006-0071PROPECIAfinasterideMerck Sharp & Dohme Corp.NDACurrent
0006-0071PROPECIAfinasterideMerck Sharp & Dohme Corp.NDACurrent
78206-152PROPECIAfinasterideOrganon LLCNDACurrent
78206-152PROPECIAfinasterideOrganon LLCNDACurrent
78206-152PROPECIAfinasterideOrganon LLCNDACurrent
78206-152PROPECIAfinasterideOrganon LLCNDACurrent
78206-152PROPECIAfinasterideOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71714SUPPL2022-08-04
71691SUPPL2022-08-02
67834SUPPL2021-06-16
67830SUPPL2021-06-16
20961SUPPL2014-07-02
20960SUPPL2014-07-02
20959SUPPL2014-07-02
20957SUPPL2014-07-02
25848SUPPL2014-02-04
13445SUPPL2014-02-03
20958SUPPL2014-01-16
25847SUPPL2012-04-12
25846SUPPL2012-04-12
3369SUPPL2012-04-12
35372SUPPL2012-04-11
35371SUPPL2012-04-11
35370SUPPL2012-04-11
23599ORIG2011-12-20
25845SUPPL2011-06-17
3370SUPPL2011-06-13
13444SUPPL2011-06-10
3368SUPPL2011-04-19
35369SUPPL2011-04-15
3367SUPPL2011-03-16
13443SUPPL2011-03-14
25844SUPPL2010-03-29
35368SUPPL2010-03-26
35367SUPPL2004-11-01
35366SUPPL2004-11-01
35362SUPPL2004-11-01
25843SUPPL2004-10-29
25842SUPPL2004-10-29
3366SUPPL2004-10-29
20956ORIG2003-08-07
13442SUPPL2003-04-24
35365SUPPL2002-04-10
35364SUPPL2002-04-10
35363SUPPL2002-04-10
3365SUPPL2002-04-10
3364SUPPL2002-04-10
3363SUPPL2002-04-10