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 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MIDAZOLAMMIDAZOLAM HYDROCHLORIDEHospira, Inc.b95415fa-17c2-42ab-a6b0-e628d01c94ed2026-08-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MIDAZOLAM
MidazolamMIDAZOLAM HYDROCHLORIDEOnesource Specialty Pharma Limiteda0e9a149-7a4c-4f66-91af-91695ee2e40c2026-08-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
MidazolamMIDAZOLAM HYDROCHLORIDEHospira, Inc.1abda8b8-48a8-4995-af86-39220d1aa2402026-08-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
MidazolamMIDAZOLAM HYDROCHLORIDEOnesource Specialty Pharma Limited54ed43b2-bad1-4b45-e063-6294a90a793a2026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
MidazolamMIDAZOLAM HYDROCHLORIDECardinal Health 107, LLCcbedf0bf-82a4-4214-96d5-01ac35e101f02026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
Midazolam in Sodium ChlorideMIDAZOLAMWG Critical Care, LLC.f051776f-94c5-4e34-80ed-f45b9c36881e2026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MIDAZOLAM
MidazolamMIDAZOLAM HYDROCHLORIDEHospira, Inc.affecd4d-1f78-4bbe-5a8d-86849bbdc5202026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
MidazolamMIDAZOLAMHenry Schein, Inc.3c2fd6ee-4ede-4ee4-8c05-34c93598f3812025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
generic name: MIDAZOLAM
MidazolamMIDAZOLAMHenry Schein, Inc.78e28b13-414e-4c34-a42c-caf1c3ba1f542025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
generic name: MIDAZOLAM
MidazolamMIDAZOLAMHenry Schein, Inc.90f7b7f6-d0fd-40af-bbfa-70b152e3e27c2025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
generic name: MIDAZOLAM
MidazolamMIDAZOLAM HYDROCHLORIDEREMEDYREPACK INC.d9305142-417d-4d8c-9a23-f9a1b6771cac2025-10-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
MidazolamMIDAZOLAMHenry Schein, Inc.94e1342b-f597-44c0-b8fc-b753fde04cbe2025-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
generic name: MIDAZOLAM
MidazolamMIDAZOLAMCivica, Inc.f0c8b6cd-9efc-4344-9212-fbdd3b8e2f9b2024-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
generic name: MIDAZOLAM
MidazolamMIDAZOLAMHikma Pharmaceuticals USA Inc.f8bb3427-c887-47b6-8042-8a21dc161c792024-12-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
generic name: MIDAZOLAM
MidazolamMIDAZOLAM HYDROCHLORIDEFresenius Kabi USA, LLCa91ce254-14a3-4cbf-8ab8-5da252aa3fdc2024-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
MidazolamMIDAZOLAMHikma Pharmaceuticals USA Inc.8675cdb1-c7f5-40cf-b1e0-0960b7ab117b2024-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
generic name: MIDAZOLAM
MidazolamMIDAZOLAMHikma Pharmaceuticals USA Inc.575d8bf0-7af7-427c-a231-966e2a5e070d2024-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
generic name: MIDAZOLAM
MidazolamMIDAZOLAMHikma Pharmaceuticals USA Inc.51c8bfa4-5c78-4b7a-9ffb-8f00828acadc2024-03-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
generic name: MIDAZOLAM
MidazolamMIDAZOLAM HYDROCHLORIDEFresenius Kabi USA, LLC1cc9ba6e-fa1b-405e-9de8-720c567b2a732024-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam
MidazolamMIDAZOLAM HYDROCHLORIDESteriscience Specialties Private Limited473fba4b-8754-4b1d-bba9-d9c8f6d818e02023-12-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Midazolam

Documents#

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