FDA.reportPublic FDA data

Application 022407

Type
NDA
Sponsor
THERAVANCE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIBATIVTELAVANCININJECTABLE; INJECTION250MGNoNo
002VIBATIVTELAVANCININJECTABLE; INJECTION750MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VIBATIVTELAVANCIN HYDROCHLORIDECumberland Pharmaceuticals Inc.5359b759-db7c-4672-9e8a-59c93869bd912025-12-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: VIBATIV

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42510ORIG2013-10-07
24298ORIG2013-07-03
43861ORIG2013-06-28
29697ORIG2013-06-26
17551ORIG2013-06-25