FDA.reportPublic FDA data

Application 205677

Type
NDA
Sponsor
VANDA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HETLIOZTASIMELTEONCAPSULE;ORAL20MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43068-220HetlioztasimelteonVanda Pharmaceuticals Inc.NDACurrent
43068-220HetlioztasimelteonVanda Pharmaceuticals Inc.NDACurrent
43068-220HetlioztasimelteonVanda Pharmaceuticals Inc.NDACurrent
43068-220HetlioztasimelteonVanda Pharmaceuticals Inc.NDACurrent
43068-220HetlioztasimelteonVanda Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65463SUPPL2020-12-02
65460SUPPL2020-12-01
60463SUPPL2019-10-09
60272SUPPL2019-10-07
40496SUPPL2014-12-16
10488SUPPL2014-12-16
40494ORIG2014-10-03
24501ORIG2014-03-07
22999ORIG2014-03-07
10487ORIG2014-02-03
40495ORIG2014-01-31