FDA.reportPublic FDA data

Application 212945

Type
ANDA
Sponsor
AMNEAL EU LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VASOPRESSINVASOPRESSININJECTABLE;INJECTION200UNITS/10ML(20UNITS/ML)NoNo

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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VasostrictVASOPRESSINMedical Purchasin Solutions, LLC6672a5c9-bcfd-d7fc-e053-2991aa0aef882023-06-01Warnings, Adverse reactionsName fallback
generic name: VASOPRESSIN
VasostrictVASOPRESSINMedical Purchasing Solutions, LLCd162d386-105d-e916-e053-2995a90a350c2023-05-03Warnings, Adverse reactionsName fallback
generic name: VASOPRESSIN
VasopressinVASOPRESSINAmphastar Pharmaceuticals, Inc.4e6c737d-65e8-4af4-b301-69a93affbc7f2022-08-22Warnings, Adverse reactionsName fallback
brand name: Vasopressin
generic name: VASOPRESSIN
VASOPRESSINVASOPRESSINHF Acquisition Co LLC, DBA HealthFirst7ae1c8c9-7d75-55a8-e053-2991aa0af05b2021-11-01Warnings, Adverse reactionsName fallback
brand name: VASOPRESSIN
generic name: VASOPRESSIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72044ORIG2022-09-08