FDA.reportPublic FDA data

Application 210557

Type
NDA
Sponsor
AMAG PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VYLEESI (AUTOINJECTOR)BREMELANOTIDE ACETATESOLUTION;SUBCUTANEOUSEQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64011-701VyleesibremelanotideAMAG Pharmaceuticals, Inc.NDACurrent
64011-701VyleesibremelanotideAMAG Pharmaceuticals, Inc.NDACurrent
64011-701VyleesibremelanotideAMAG Pharmaceuticals, Inc.NDACurrent
80064-141VyleesibremelanotidePalatin TechnologiesNDACurrent
80064-141VyleesibremelanotidePalatin TechnologiesNDACurrent
80064-141VyleesibremelanotidePalatin TechnologiesNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65041SUPPL2020-10-27
65030SUPPL2020-10-27
59579ORIG2019-08-06
59164ORIG2019-08-02
59159ORIG2019-06-21