FDA.reportPublic FDA data

Application 020032

Type
BLA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SURVANTABERACTANTSUSPENSION;INTRATRACHEAL25MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-1040SurvantaBeractantAbbVie Inc.BLACurrent
0074-1040SurvantaBeractantAbbVie Inc.BLACurrent
0074-1040SurvantaBeractantAbbVie Inc.BLACurrent
0074-1040SurvantaBeractantAbbVie Inc.BLACurrent
0074-1040SurvantaBeractantAbbVie Inc.BLACurrent
0074-1040SurvantaBeractantAbbVie Inc.BLACurrent
0074-1040SurvantaBeractantAbbVie Inc.NDACurrent
0074-1040SurvantaBeractantAbbVie Inc.NDACurrent
0074-1040SurvantaBeractantAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71730SUPPL2022-08-05
71700SUPPL2022-08-03
65105SUPPL2020-10-30
65043SUPPL2020-10-27
62237APPL2020-03-23
61332SUPPL2020-03-23
61324SUPPL2020-03-23
21059SUPPL2020-03-23
21058SUPPL2020-03-23
1927SUPPL2020-03-23