FDA.reportPublic FDA data

Application 216048

Type
ANDA
Sponsor
CIPLA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIDAZOLAMMIDAZOLAMSPRAY;NASAL5MGNoNo

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 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MidazolamMIDAZOLAM HYDROCHLORIDESOMERSET THERAPEUTICS, LLC06e4f754-72df-4eb4-aaed-b538524f52772023-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
midazolamMIDAZOLAM HYDROCHLORIDESagent Pharmaceuticals880cac48-5c0f-49a9-8aef-3c9770bf5d842023-11-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: midazolam
midazolamMIDAZOLAM HYDROCHLORIDESagent Pharmaceuticalse22611dd-1830-40af-9139-7cdb07f5a4262023-11-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: midazolam
MidazolamMIDAZOLAMMicro Labs Limited9221894f-d840-46f2-a11c-6b71358d3b5b2023-08-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
generic name: MIDAZOLAM
NayzilamMIDAZOLAMUCB, Inc.2b29422e-54d5-4a49-8522-e9cf752368c32023-01-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MIDAZOLAM

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72936ORIG2022-12-20