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 5 of 9 · 178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEDoc Rxd4457b8c-fff8-4c19-8d5a-a667161e54462025-09-04Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutionseb908b77-741c-473a-b2e9-4f82167c30882025-08-26Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutions4923ac1f-d463-465b-9e99-7312aef878612025-08-26Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutionsd6448bb1-9b8d-45f4-a14b-8328248e586e2025-08-26Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC3bddfe25-00ba-747f-e063-6394a90a9ce62025-08-08Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINEAphena Pharma Solutions - Tennessee, LLC3bc7e2b4-e1a0-66e3-e063-6294a90a676a2025-08-07Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.820dca15-5b7f-41e0-955f-73f9427092642025-08-01Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDESOLA Pharmaceuticals, LLCdb930d05-3f92-41f1-888c-301b2c4565e62025-07-30Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAvKAREa264ab9f-cc12-325f-e053-2a95a90a53d92025-07-24Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEPHOENIX RX LLC3a90171b-aef3-0691-e063-6294a90a65602025-07-22Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPHOENIX RX LLC3a116427-c427-c3bc-e063-6294a90ac5392025-07-21Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack6536b470-9a4e-4174-85b8-479f64cc32962025-07-14Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.e3b5fc92-9186-6944-e053-2a95a90a1c9f2025-07-08Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDECoupler LLC37c8c0d6-98c0-c1a5-e063-6394a90a79312025-06-17Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC34f4e63a-1259-0226-e063-6294a90a9fc42025-06-16Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCdd546a0e-e5be-4232-8ad8-fcd7d5f9a9032025-05-27Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.59b428fa-5013-4b2b-872f-16ba4a9d4f5d2025-05-01Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9161cb5e-63e5-41d7-9bde-66c7b7b7a2f32025-05-01Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3aaa4808-7f2d-410c-9b6c-193549ec08452025-04-30Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7829a96a-3668-4d88-90e9-0ecbedb2bd7e2025-04-30Warnings, 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.