Application 020638

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VISTIDECIDOFOVIRINJECTABLE;INJECTIONEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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
61958-0101VistideCIDOFOVIRGilead Sciences, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57683ORIG2019-02-15
35053SUPPL2005-01-28