FDA.reportPublic FDA data

Application 020264

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEGACEMEGESTROL ACETATESUSPENSION;ORAL40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0015-0508MEGACEMEGESTROL ACETATEE.R. Squibb & Sons, L.L.CNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59383SUPPL2019-07-19
59379SUPPL2019-07-19
2271SUPPL2012-04-11
34453SUPPL2012-04-09
41254ORIG2011-12-14
2270SUPPL2003-05-30
2269SUPPL2002-04-09