FDA.reportPublic FDA data

Application 021640

Type
BLA
Sponsor
BAUSCH AND LOMB

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021640Vitrasehyaluronidase351(a)Disc2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VITRASEHYALURONIDASEINJECTABLE;INJECTION6,200 UNITS/VIALNoNo
002VITRASEHYALURONIDASEINJECTABLE;INJECTION200 UNITS/VIALNoNo

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYLENEX RecombinantHYALURONIDASEAntares Pharma, Inc.3023cc56-ed4b-4e87-b3a1-81b20943f6582024-11-11Warnings, Adverse reactionsName fallback
generic name: HYALURONIDASE
AMPHADASEHYALURONIDASEAmphastar Pharmaceuticals, Inc.8396ea96-7cb5-4e26-87a4-90bca9c3c6dd2024-02-01Warnings, Adverse reactionsName fallback
generic name: HYALURONIDASE
HYALURONIDASEHYALURONIDASEHF Acquisition Co LLC, DBA HealthFirstc3f1db01-58bf-2226-e053-2a95a90a8b332021-06-04Warnings, Adverse reactionsName fallback
generic name: HYALURONIDASE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-002VITRASEhyaluronidase, ovineBausch & Lomb IncorporatedBLACurrent
24208-002VITRASEhyaluronidase, ovineBausch & Lomb IncorporatedNDACurrent
24208-002VITRASEhyaluronidase, ovineBausch & Lomb IncorporatedNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77226SUPPL 2024-01-16
77216SUPPL 2024-01-16
62382APPL2020-03-31
54376SUPPL2020-03-23
54371SUPPL2020-03-23
44482ORIG2020-03-23
37380SUPPL2020-03-23
37379SUPPL2020-03-23
37378SUPPL2020-03-23
37377SUPPL2020-03-23
37376ORIG2020-03-23
28293SUPPL2020-03-23
28292SUPPL2020-03-23
28291SUPPL2020-03-23
28290ORIG2020-03-23
21764ORIG2020-03-23
5899SUPPL2020-03-23