Application 019915

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002MONOPRILFOSINOPRIL SODIUMTABLET;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003MONOPRILFOSINOPRIL SODIUMTABLET;ORAL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004MONOPRILFOSINOPRIL SODIUMTABLET;ORAL40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
1811SUPPL2009-02-13
23561ORIG2006-06-09
19843SUPPL2003-11-05
41094SUPPL2003-07-08
34099SUPPL2003-06-08
1810SUPPL2003-06-08
19842SUPPL2002-08-29
51963SUPPL1900-01-01
51962SUPPL1900-01-01
51961SUPPL1900-01-01
51960SUPPL1900-01-01