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 1 of 9 · 178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.5d536e88-62be-45bd-bd09-0efc53fe12b92026-09-09Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDESportpharm LLC71185d15-3fd7-42b7-83a6-8357e3aaef432026-09-05Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.37056cab-953e-43ba-9b4c-163a739a52f72026-09-02Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.30e61110-5bc8-4134-8456-5385584797352026-09-01Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.ba659e1a-0091-45f6-b418-f4f36c9a2c792026-08-31Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.3175d24d-e8a0-4f14-bed9-a60ad59ac7e72026-08-28Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_Rx903e3a5a-7c58-b70d-e053-2a95a90a6f9d2026-08-27Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.e4ed7ad2-cf58-4fdb-bc8c-d89f23b012102026-08-17Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEUnit Dose Solutions, Inc.53bef1ab-55c0-cc52-e063-6394a90a12b32026-08-17Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
TONMYACYCLOBENZAPRINE HYDROCHLORIDETonix Medicines, Inc.6fa59588-ce9b-48cf-8c5f-725a448f85712026-08-14Warnings, Adverse reactionsName fallback
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDERedpharm Drug58e6d82b-52fd-cca3-e063-6294a90a11042026-08-13Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.b09ca979-ab6b-441b-a66f-41ca32eae6cb2026-08-10Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.8bef97d4-1b92-4316-8733-7751d627230f2026-08-07Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.eb2b24b1-2851-440f-9075-b6a123a1fd5c2026-08-05Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDECardinal Health 107, LLCdf902d94-9d2b-4139-aebb-3eb6b8b8cd542026-07-30Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.f2eb32c3-3da0-4938-9ed9-ea8420450fde2026-07-27Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8c66b5ed-f773-0779-e053-2995a90ad1f12026-07-20Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETruPharma LLC08adc97f-feef-46fb-ac75-f015b4f3a43a2026-07-17Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4ee4feec-4590-fa7f-e063-6394a90a55502026-07-17Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.84be93c5-1526-465e-ab0b-c6d10ba1521d2026-07-15Warnings, 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.