FDA.reportPublic FDA data

Application 090864

Type
ANDA
Sponsor
PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE; ORAL15MGNoNo
002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE; ORAL30MGNoNo

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 8 of 9 · 178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.ca74d27a-f7c6-462d-a913-1cfa061bd8f32024-05-31Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutionsd64ca498-81c6-4e10-ba82-3a50ee47bcfc2024-05-29Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.07e3ec53-f1f2-4231-aec6-1772a146ba882024-05-07Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
AMRIXCYCLOBENZAPRINE HYDROCHLORIDECephalon, LLC3902123b-1365-ac3c-0934-afff9eeeb1bd2024-04-30Warnings, Adverse reactionsName fallback
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.00dbe051-a392-e2c6-e063-6394a90ab7f32024-03-27Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.0f8ba2c0-38e7-a536-e063-6294a90ace8d2024-03-26Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.c68d17e2-2311-8e17-e053-2995a90a565b2024-03-11Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEMedsource Pharmaceuticals12645f19-fffc-8b08-e063-6394a90a5c552024-02-27Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack90c7a982-6442-4241-a60b-b5dfab2abb712024-01-31Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepackc86303a0-7c8b-415e-acac-1070b7d0d4452024-01-15Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LP34ff8a08-0177-451f-9dbc-e215823461962024-01-01Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC31bb92f6-ec8c-4636-8b07-8814417fe78e2023-12-31Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack4a2d3cae-5c64-4986-9707-cc213b70b7ad2023-10-19Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack85128989-bfa3-4b82-94c1-f90b14ccd2f92023-10-18Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.74af1727-e84f-4dad-82be-045e7d23beaf2023-09-06Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LP88bdee56-d6d9-4f14-be77-1e6898ba36f52023-09-01Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack6ebaccfc-f57c-4547-ade0-6a6e204f5ea02023-03-27Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.68db3c3b-8da1-4852-90b0-3172f842aa022023-03-02Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutionsb524d150-0a83-42d1-a884-b930e49760cd2023-02-06Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.1adcdd8a-30f9-4a7b-853c-948a5589acab2023-01-03Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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