FDA.reportPublic FDA data

Application 089815

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BETHANECHOL CHLORIDEBETHANECHOL CHLORIDEInjectable; Injection5MG/MLNoNo

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 1 ยท 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bethanechol ChlorideBETHANECHOL CHLORIDEAmneal Pharmaceuticals of New York LLC16523451-cd3d-4c10-be06-d59a6f12ac682026-01-29Adverse reactionsName fallback
brand name: Bethanechol Chloride
generic name: BETHANECHOL CHLORIDE
Bethanechol ChlorideBETHANECHOL CHLORIDEHeritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.11ba3d38-a61b-4b03-ba03-4ccf2e450d1f2025-10-27Adverse reactionsName fallback
brand name: Bethanechol Chloride
generic name: BETHANECHOL CHLORIDE
Bethanechol ChlorideBETHANECHOL CHLORIDEAmerican Health Packagingda12a817-9f34-4f26-a7dc-e0e8f9be91c32024-12-02Adverse reactionsName fallback
brand name: Bethanechol Chloride
generic name: BETHANECHOL CHLORIDE
Bethanechol ChlorideBETHANECHOL CHLORIDEAmneal Pharmaceuticals LLC45285692-de51-413e-8a51-7fb792eccc812024-10-23Adverse reactionsName fallback
brand name: Bethanechol Chloride
generic name: BETHANECHOL CHLORIDE
Bethanechol ChlorideBETHANECHOL CHLORIDEChartwell RX, LLC89267333-ba8b-455b-a8dc-515a888463c22024-01-22Adverse reactionsName fallback
brand name: Bethanechol Chloride
generic name: BETHANECHOL CHLORIDE

Reported adverse events (FAERS/openFDA)#

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