FDA.reportPublic FDA data

Application 212640

Type
NDA
Sponsor
AQUESTIVE THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXSERVANRILUZOLEFILM;ORAL50MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10094-350EXSERVANriluzoleAquestive TherapeuticsNDACurrent
10094-350EXSERVANriluzoleAquestive TherapeuticsNDACurrent
70510-2201ExservanriluzoleMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2201ExservanriluzoleMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2201ExservanriluzoleMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2201ExservanriluzoleMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2202ExservanriluzoleMitsubishi Tanabe Pharma America, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62947SUPPL2020-05-13
62922SUPPL2020-05-12
62592ORIG2020-04-17
61039ORIG2019-11-26
61038ORIG2019-11-22