FDA.reportPublic FDA data

Application 761148

Type
BLA
Sponsor
SPECTRUM PHARMS

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761148Rolvedoneflapegrastim-xnst351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROLONTISEFLAPEGRASTIM-XNSTINJECTABLE;SUBCUTANEOUS13.2MG/0.6MLNoNo

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RolvedonEFLAPEGRASTIM-XNSTSpectrum Pharmaceuticals, Inc.6e436115-62e7-4729-aeb0-ff78ea6852062026-02-18Warnings, Adverse reactionsExact identifier
application number: BLA761148
ndc (product): 76961-101
RolvedonEFLAPEGRASTIM-XNSTAssertio Specialty Pharmaceuticals, LLC2dc62c46-bb10-4a62-a459-d3eeeb6dd82f2026-02-11Warnings, Adverse reactionsExact identifier
application number: BLA761148

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
76961-101Rolvedoneflapegrastim-xnstSpectrum Pharmaceuticals, Inc.BLACurrent
76961-101Rolvedoneflapegrastim-xnstSpectrum Pharmaceuticals, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84437SUPPL 2025-12-18
84436SUPPL 2025-12-18
74546SUPPL 2023-06-20
74540SUPPL 2023-06-20
72293ORIG2022-10-11
72089ORIG2022-09-16
72074ORIG2022-09-13