Unichem Laboratories has received ANDA approval for its Cyclobenzaprine Hydrochloride Tablets USP, 5 mg, 7.5 mg and 10 mg from the United States Food and Drug Administration (USFDA) to market a generic version of FLEXERIL (Cyclobenzaprine HCI) Tablets, 5 mg and 10 mg of Janssen Research and Development LLC.
Cyclobenzaprine HCI Tablets are indicated for the treatment as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. The product will be commercialized from Unichem's Goa Plant.
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