Application 020863

Type
NDA
Sponsor
OTSUKA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PLETALCILOSTAZOLTABLET;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002PLETALCILOSTAZOLTABLET;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48454SUPPL2017-05-19
48449SUPPL2017-05-18
13637SUPPL2015-08-04
26076SUPPL2015-07-31
13636SUPPL2015-01-29
26075SUPPL2015-01-26
13635SUPPL2007-11-19
3601SUPPL2007-11-19
26074SUPPL2007-01-25
13634SUPPL2007-01-24
35526SUPPL2005-11-30
26073SUPPL2005-11-30
13633ORIG2004-06-14
3600SUPPL2004-03-03
21027ORIG1999-01-15
3599ORIG1999-01-15