FDA.reportPublic FDA data

Application 089852

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORZOXAZONECHLORZOXAZONETABLET;ORAL250MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089852-001CHLORZOXAZONECHLORZOXAZONE250MGTABLET / ORAL1988-05-04

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A089852-001CHLORZOXAZONE250MGTABLET / ORAL1988-05-04a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHLORZOXAZONECHLORZOXAZONEBryant Ranch Prepack6c77ca6b-fda6-43ab-8179-3e0bde6aa65f2026-04-13Warnings, Adverse reactionsName fallback
brand name: CHLORZOXAZONE
generic name: CHLORZOXAZONE
CHLORZOXAZONECHLORZOXAZONEREMEDYREPACK INC.3f73a1d1-b3ee-4678-bc02-3258ec8121272026-01-29Warnings, Adverse reactionsName fallback
brand name: CHLORZOXAZONE
generic name: CHLORZOXAZONE
ChlorzoxazoneCHLORZOXAZONEPD-Rx Pharmaceuticals, Inc.8650d342-92df-48d7-9f3d-cdd6f6f4c0e72025-10-20Warnings, Adverse reactionsName fallback
brand name: Chlorzoxazone
generic name: CHLORZOXAZONE
CHLORZOXAZONECHLORZOXAZONEHappy Robin, LLC3f90c7bc-118f-4371-e063-6394a90a279a2025-10-08Warnings, Adverse reactionsName fallback
brand name: CHLORZOXAZONE
generic name: CHLORZOXAZONE
chlorzoxazoneCHLORZOXAZONESolubiomixc3d40a90-6df8-4b44-bc61-d7655c52bacb2025-10-06Warnings, Adverse reactionsName fallback
brand name: chlorzoxazone
generic name: CHLORZOXAZONE
ChlorzoxazoneCHLORZOXAZONERising Pharma Holdings, Inc.e0d10d67-9716-450b-b8a9-4e157008864e2025-09-17Warnings, Adverse reactionsName fallback
brand name: Chlorzoxazone
generic name: CHLORZOXAZONE
CHLORZOXAZONECHLORZOXAZONEAdvanced Rx of Tennessee, LLC36c1eb43-8840-8d84-e063-6394a90addca2025-05-29Warnings, Adverse reactionsName fallback
brand name: CHLORZOXAZONE
generic name: CHLORZOXAZONE
CHLORZOXAZONECHLORZOXAZONEAdvanced Rx of Tennessee, LLC30c9b3ce-198d-0c16-e063-6394a90a857d2025-03-20Warnings, Adverse reactionsName fallback
brand name: CHLORZOXAZONE
generic name: CHLORZOXAZONE
ChlorzoxazoneCHLORZOXAZONELifsa Drugs LLC0f222059-1ece-44f3-ae7f-d277e5bcaba42025-03-16Warnings, Adverse reactionsName fallback
brand name: Chlorzoxazone
generic name: CHLORZOXAZONE
CHLORZOXAZONECHLORZOXAZONECamber Pharmaceuticals, Inc.e9bb9ebf-fceb-4da8-950a-c4b1fd5a84f12025-03-16Warnings, Adverse reactionsName fallback
brand name: CHLORZOXAZONE
generic name: CHLORZOXAZONE
CHLORZOXAZONECHLORZOXAZONEProficient Rx LP0a8ee5fa-f393-4568-81bd-269f9a4cecd62025-03-01Warnings, Adverse reactionsName fallback
brand name: CHLORZOXAZONE
generic name: CHLORZOXAZONE
CHLORZOXAZONECHLORZOXAZONEA-S Medication Solutionsd0210638-b828-4c05-9669-fd61ef9873172025-02-04Warnings, Adverse reactionsName fallback
brand name: CHLORZOXAZONE
generic name: CHLORZOXAZONE
ChlorzoxazoneCHLORZOXAZONEAdvanced Rx Pharmacy of Tennessee, LLCf8ff7293-89b6-b6ee-e053-6394a90a7d392024-12-31Warnings, Adverse reactionsName fallback
brand name: Chlorzoxazone
generic name: CHLORZOXAZONE
ChlorzoxazoneCHLORZOXAZONEEndo USA, Inc.7c5a835d-3754-4c25-a0e2-335b8eceb2d22024-12-03Warnings, Adverse reactionsName fallback
brand name: Chlorzoxazone
generic name: CHLORZOXAZONE
ChlorzoxazoneCHLORZOXAZONEBryant Ranch Prepack5e6889c9-a091-4622-0a00-ad0fc1830f782024-10-08Warnings, Adverse reactionsName fallback
brand name: Chlorzoxazone
generic name: CHLORZOXAZONE
CHLORZOXAZONECHLORZOXAZONEBryant Ranch Prepackd7f09907-83b2-46cf-947d-fa38dcf886852024-09-09Warnings, Adverse reactionsName fallback
brand name: CHLORZOXAZONE
generic name: CHLORZOXAZONE
ChlorzoxazoneCHLORZOXAZONEActavis Pharma, Inc.2f05e8e2-616f-475b-ac9f-c42e1a5dbe812024-08-25Warnings, Adverse reactionsName fallback
brand name: Chlorzoxazone
generic name: CHLORZOXAZONE
CHLORZOXAZONECHLORZOXAZONEBryant Ranch Prepack669afcc1-d587-4dc0-8f6e-99109bcfed362024-04-03Warnings, Adverse reactionsName fallback
brand name: CHLORZOXAZONE
generic name: CHLORZOXAZONE
CHLORZOXAZONECHLORZOXAZONECintex Services, LLC13a1aa33-6971-da5a-e063-6394a90a9e122024-03-21Warnings, Adverse reactionsName fallback
brand name: CHLORZOXAZONE
generic name: CHLORZOXAZONE
CHLORZOXAZONECHLORZOXAZONEAurobindo Pharma Limited52d3aa2c-f88f-4de7-b5ae-df8a46e948792023-09-05Warnings, Adverse reactionsName fallback
brand name: CHLORZOXAZONE
generic name: CHLORZOXAZONE