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Corporate - Regulatory Bodies & Rulings
Aurobindo drug gets US nod

Hyderabad, Oct. 10

Aurobindo Pharma Ltd has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Cyclobenzaprine Hydrochloride tablets in 5 mg and 10 mg. The tablet is the generic version of Mcneil-PPC's Flexeril tablets (5 mg and 10 mg). It is indicated as an adjunct for relief of muscle spasm. The approval was the 79th Abbreviated New Drug Application (ANDA) from USFDA, according to a release. - Our Bureau

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