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 6 of 9 · 178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3baeda95-d098-437a-b360-87a9c3f3fd9b2025-04-30Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDERedpharm Drug0ab1b6f8-5d73-f97a-e063-6294a90a9fbf2025-04-09Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
FexmidCYCLOBENZAPRINE HYDROCHLORIDERising Pharma Holdings, Inc.41838966-de0b-4855-83b8-2ff6c764ed1f2025-04-07Warnings, Adverse reactionsName fallback
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack3f1b9c8a-8f75-4b84-af0c-739815937fd72025-04-01Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack2169667d-4f4b-472d-929b-8a0bcbddbe9c2025-03-26Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepackdcef9b63-f998-4852-920d-c356623cea6a2025-03-21Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC30ca08c7-4ee3-2f37-e063-6294a90ae31a2025-03-20Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEJubilant Cadista Pharmaceuticals Inc.592871f6-0eb2-4624-9e10-bd8bf767c0022025-02-21Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDERising Pharma Holdings, Inc.6018b6e9-938d-4fc9-86d7-1fd1d7bfcc582025-02-20Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEUpsher-Smith Laboratories, LLC14f64ceb-ea5c-4d7c-a0c1-3f6a648472902025-02-20Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepackaa29e260-fb77-415a-a505-3230d30c89452025-02-10Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.fbd38abb-02ae-1a36-e053-6294a90abe652025-02-04Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.418e3974-f7dd-4f27-bee5-3c2fb0531c4c2025-02-03Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack05641925-7b10-4b30-b6e8-44b416a5e77e2025-02-03Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack96207b29-033b-46a3-961f-e5125288d50f2025-02-03Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDERedpharm Drug, Inc.09d0e2fc-76a4-bb7d-e063-6394a90a4a7d2025-01-23Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDERedpharm Drugfc61c9f5-b0ec-3ff8-e053-6394a90adeb72025-01-23Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDERedpharm Drug09d35c34-11fa-3a5d-e063-6294a90ab1722025-01-23Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirectRxceb56ab8-4a76-6dee-e053-2995a90aab302025-01-20Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDIRECT RXa58cf759-048b-6740-e053-2a95a90a8b432025-01-17Warnings, 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.